<?xml version="1.0" encoding="UTF-8" standalone="no"?><?xml-stylesheet href="../../stylesheet/spl.xsl" type="text/xsl"?><document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
  <id root="c7df0ca8-1f2f-556f-e053-2995a90a195e"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>PainONil 25g Tube for Sustained and Rapid Pain Relief</title>
  <effectiveTime value="20210724"/>
  <setId root="c62451b0-771e-a774-e053-2995a90a37d8"/>
  <versionNumber value="5"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="117103844" root="1.3.6.1.4.1.519.1"/>
        <name>PhytoBiologic Pharmaceutics LLC</name>
        <assignedEntity>
          <assignedOrganization>
            <id extension="117103844" root="1.3.6.1.4.1.519.1"/>
            <name>PhytoBiologic Pharmaceutics LLC</name>
            <assignedEntity>
              <assignedOrganization>
                <id extension="117103844" root="1.3.6.1.4.1.519.1"/>
                <name>PhytoBiologic Pharmaceutics LLC</name>
              </assignedOrganization>
              <performance>
                <actDefinition>
                  <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="manufacture"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="73417-758" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
              <performance>
                <actDefinition>
                  <code code="C84732" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="label"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="73417-758" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
            </assignedEntity>
          </assignedOrganization>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="c7df16f9-34d2-7ab1-e053-2a95a90a6638"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
          <effectiveTime value="20210724"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="73417-758" codeSystem="2.16.840.1.113883.6.69"/>
                <name>PainONil</name>
                <formCode code="C42966" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OINTMENT"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Eugenol, Camphor, Eucalyptus</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="654825W09Z" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FENUGREEK SEED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="TYY1MA9BSY" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MUSTARD OIL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="4T6H12BN9U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PETROLATUM</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="80"/>
                    <denominator unit="g" value="1"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="N20HL7Q941" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CAMPHOR (NATURAL)</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="N20HL7Q941" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CAMPHOR (NATURAL)</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="20"/>
                    <denominator unit="g" value="1"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="3T8H1794QW" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>EUGENOL</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="3T8H1794QW" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>EUGENOL</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="AV092KU4JH" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PEPPERMINT OIL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="HKY915780T" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>AZADIRACHTA INDICA LEAF</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="2ZA36H0S2V" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>YELLOW WAX</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="4V873H15CG" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>RUBIA CORDIFOLIA ROOT</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="50"/>
                    <denominator unit="g" value="1"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="2R04ONI662" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>EUCALYPTUS OIL</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="2R04ONI662" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>EUCALYPTUS OIL</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="ZY81Z83H0X" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ALOE VERA LEAF</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="856YO1Z64F" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TURMERIC</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="77539R6FGN" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ONION JUICE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="C5529G5JPQ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GINGER</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="6Y89129C8H" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ANISE OIL</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="g" value="25"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="73417-758-52" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20210812"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <approval>
                  <id extension="part348" root="2.16.840.1.113883.3.149"/>
                  <code code="C73604" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC monograph not final"/>
                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                      </territory>
                    </territorialAuthority>
                  </author>
                </approval>
              </subjectOf>
              <subjectOf>
                <marketingAct>
                  <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <statusCode code="active"/>
                  <effectiveTime>
                    <low value="20210812"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48330" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="yellow" xsi:type="CE">
                    <originalText/>
                  </value>
                </characteristic>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
          </subject>
        </section>
      </component>
      <component>
        <section ID="id_link_a730126d-9e33-4c77-e053-2a95a90a5707">
          <id root="c7bd6f60-dfdd-790f-e053-2995a90acbb9"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>PainONil Active Ingredients</title>
          <text>
            <paragraph/>
            <table border="1" cellpadding="0" cellspacing="0">
              <tbody>
                <tr>
                  <td>
                    <paragraph>
                      <content styleCode="bold">Active Ingredient</content>
                    </paragraph>
                  </td>
                  <td>
                    <paragraph>
                      <content styleCode="bold">Strength</content>
                    </paragraph>
                  </td>
                  <td>
                    <paragraph>
                      <content styleCode="bold">Purpose</content>
                    </paragraph>
                  </td>
                </tr>
                <tr>
                  <td>
                    <paragraph>Camphor</paragraph>
                  </td>
                  <td>
                    <paragraph>8%</paragraph>
                  </td>
                  <td>
                    <paragraph>External analgesic</paragraph>
                  </td>
                </tr>
                <tr>
                  <td>
                    <paragraph>Eucalyptus oil</paragraph>
                  </td>
                  <td>
                    <paragraph>5%</paragraph>
                  </td>
                  <td>
                    <paragraph>External analgesic</paragraph>
                  </td>
                </tr>
                <tr>
                  <td>Eugenol</td>
                  <td>2%</td>
                  <td>Analgesic &amp; Anesthetic</td>
                </tr>
              </tbody>
            </table>
            <paragraph/>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a730193d-5a18-a630-e053-2995a90a6341">
          <id root="c7bd6f60-dfdc-790f-e053-2995a90acbb9"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>
              <content styleCode="bold">For rapid and sustained relief of pain.</content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a730126d-9e35-4c77-e053-2a95a90a5707">
          <id root="c7bceb66-d226-7977-e053-2995a90a38fd"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <paragraph>For rapid and sustained relief of pain in joints, muscles, and tendons caused due to:</paragraph>
            <list listType="unordered">
              <item>Sprains</item>
              <item>sports injuries</item>
              <item>falls</item>
              <item>back &amp; neck injuries</item>
              <item>inﬂammation</item>
              <item>swelling</item>
              <item>excessive use of joints</item>
            </list>
            <paragraph/>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a73019f7-6448-eee5-e053-2995a90a1cfc">
          <id root="c7bceb66-d229-7977-e053-2995a90a38fd"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <text>
            <list listType="unordered">
              <item>For external use only.</item>
              <item>Avoid contact with eyes and mucous membranes.</item>
              <item>Use only as directed.</item>
              <item>Stop use and consult a doctor if: Skin rash or allergy occurs.</item>
              <item>If pregnant or breast-feeding, or symptoms persist, consult medical professional.</item>
              <item>Keep out of children's reach. If swallowed, get immediate medical help.</item>
            </list>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a72fb23f-eea7-43f6-e053-2a95a90a5f57">
          <id root="c7bcfa26-e6f4-dc95-e053-2995a90ab9f4"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <paragraph>Apply a generous amount of the ointment (~1g) on the affected area 3 times daily and massage gently. For faster results*, apply mild heat at the effected area with a heat lamp or heat pad after each application.</paragraph>
            <paragraph/>
            <paragraph>Do not use for children under 5 years of age.</paragraph>
            <paragraph>
              <br/>
* Individual results may vary.
 </paragraph>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="img_c7bceb66-d22b-7977-e053-2995a90a38fd"/>
            </paragraph>
            <paragraph/>
          </text>
          <effectiveTime value="20210812"/>
          <component>
            <observationMedia ID="img_c7bceb66-d22b-7977-e053-2995a90a38fd">
              <text>PainONil DrugFact</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="PON_durgfact.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
      <component>
        <section ID="id_link_a73029c3-7c2a-2768-e053-2995a90a5ebc">
          <id root="c67d896a-0e04-3822-e053-2a95a90a4e9f"/>
          <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
          <title>When Using This Product</title>
          <text>
            <list listType="unordered">
              <item>Do not apply excessive external heat</item>
            </list>
            <paragraph/>
          </text>
          <effectiveTime value="20210809"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a73029c3-7c2d-2768-e053-2995a90a5ebc">
          <id root="c7bcbdcb-ad0c-b76a-e053-2a95a90adee4"/>
          <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
          <title>Stop Use Section</title>
          <text>
            <paragraph>Stop use of this product and consult a doctor If:</paragraph>
            <paragraph/>
            <list listType="unordered">
              <item>Skin rash occurs</item>
            </list>
            <paragraph/>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a730216f-c6a2-02a8-e053-2995a90ac04c">
          <id root="c7bcfa26-e6f6-dc95-e053-2995a90ab9f4"/>
          <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
          <title>If pregnant or breat feeding</title>
          <text>
            <paragraph>If pregnant or breast-feeding, or symptoms persist, consult medical professional before use</paragraph>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_c67e2ed8-fa13-49c0-e053-2a95a90a785f">
          <id root="c7bcbdcb-ad0e-b76a-e053-2a95a90adee4"/>
          <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
          <title>Keep Out of Reach of Children</title>
          <text>
            <paragraph>Keep out of children's reach. 
  <content styleCode="bold">If swallowed, get immediate medical help.</content>
            </paragraph>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a72ef602-d97b-4604-e053-2a95a90aa22c">
          <id root="c7bd425d-26a4-07d3-e053-2a95a90a018d"/>
          <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
          <title>Other Information</title>
          <text>
            <list listType="unordered">
              <item>Store in room temperature 40
   <sup>0</sup>F to 86
   <sup>0</sup>F (4
   <sup>0</sup>C to 30
   <sup>0</sup>C)
  </item>
              <item>Bioactive formula has a natural color that can stain cloths</item>
            </list>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="img_c7bcbdcb-ad0f-b76a-e053-2a95a90adee4"/>
            </paragraph>
          </text>
          <effectiveTime value="20210812"/>
          <component>
            <observationMedia ID="img_c7bcbdcb-ad0f-b76a-e053-2a95a90adee4">
              <text>PainONil Inner Label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="PainOnil-TubeInnerLabel.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
      <component>
        <section ID="id_link_a72ff32f-4897-56e7-e053-2a95a90ac636">
          <id root="c7bcfa26-e6f7-dc95-e053-2995a90ab9f4"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive Ingredients</title>
          <text>
            <paragraph>Inactive ingredients
  <br/>
Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.
 </paragraph>
            <paragraph/>
          </text>
          <effectiveTime value="20210809"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a72ff32f-48ac-56e7-e053-2a95a90ac636">
          <id root="c7bcfa26-e6f8-dc95-e053-2995a90ab9f4"/>
          <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
          <title>Questions or Comments ?</title>
          <text>
            <paragraph>
              <renderMultiMedia referencedObject="img_c7bd0411-ed80-4dc0-e053-2a95a90a1522"/>
            </paragraph>
            <paragraph/>
          </text>
          <effectiveTime value="20210809"/>
          <component>
            <observationMedia ID="img_c7bd0411-ed80-4dc0-e053-2a95a90a1522">
              <text>PainONil Contact</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="PON_contact.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
      <component>
        <section ID="id_link_c7bceb66-d228-7977-e053-2995a90a38fd">
          <id root="c7bceb66-d22c-7977-e053-2995a90a38fd"/>
          <code code="43683-2" codeSystem="2.16.840.1.113883.6.1" displayName="RECENT MAJOR CHANGES SECTION"/>
          <text>
            <list listType="unordered">
              <item>Active Ingredients (Camphor -- 8% External analgesic, Eucalyptus Oil -- 5% External analgesic, Eugenol -- 2% Analgesic &amp; Anesthetic)</item>
              <item>Inactive ingredients
   <br/>
	Aloe vera extract, Anise seed extract, Azadirachta indica extract, Beeswax, Curcuma longa root extract, Fenugreek seed extract, Fragrance, Ginger extract, Mustard oil, Onion extract, Peppermint oil, Petroleum jelly, Rubia cordifolia extract.
  </item>
            </list>
          </text>
          <effectiveTime value="20210812"/>
        </section>
      </component>
      <component>
        <section ID="id_link_a73061fb-d2a2-036c-e053-2a95a90a0eac">
          <id root="c7bcff11-d0f0-3544-e053-2995a90a0de6"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Principal Display Panel - 25 g Tube &amp; Carton</title>
          <text>
            <paragraph>
              <content styleCode="bold">PainONil
   <sup>TM</sup> - 25 g Tube &amp; Carton
   <br/>
NDC 73417-718-25
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Net Wt: 0.90 OZ (25g)</content>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_c7bcff11-d0ef-3544-e053-2995a90a0de6"/>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20210812"/>
          <component>
            <observationMedia ID="img_c7bcff11-d0ef-3544-e053-2995a90a0de6">
              <text>PainONil Outer Label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="PainOnil-TubeOuterLabel.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>