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  <title>ADAPALENE</title>
  <effectiveTime value="20250908"/>
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  <versionNumber value="4"/>
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    <time/>
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      <representedOrganization>
        <id extension="006961700" root="1.3.6.1.4.1.519.1"/>
        <name>Target Corporation</name>
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              <assignedOrganization>
                <id extension="243339023" root="1.3.6.1.4.1.519.1"/>
                <name>Sun Pharma Canada Inc.	</name>
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                <name>ADAPALENE</name>
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                    <name>Adapalene</name>
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                    <code code="4Q93RCW27E" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)</name>
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                    <name>EDETATE DISODIUM</name>
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                    <code code="HIE492ZZ3T" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PHENOXYETHANOL</name>
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                    <code code="JX0HIX6OAG" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLOXAMER 182</name>
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                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PROPYLENE GLYCOL</name>
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                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
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                    <code code="55X04QC32I" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM HYDROXIDE</name>
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                    <numerator unit="mg" value="1"/>
                    <denominator unit="g" value="1"/>
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                    <code code="1L4806J2QF" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ADAPALENE</name>
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                      <activeMoiety>
                        <code code="1L4806J2QF" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>ADAPALENE</name>
                      </activeMoiety>
                    </activeMoiety>
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                </ingredient>
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                    <numerator unit="g" value="15"/>
                    <denominator value="1"/>
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                    <formCode code="C42794" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TUBE"/>
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                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
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                          <statusCode code="active"/>
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                            <low value="20240719"/>
                          </effectiveTime>
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                <approval>
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                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20240723"/>
        </section>
      </component>
      <component>
        <section>
          <id root="3e515a45-7c46-1e08-e063-6294a90a9621"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient</title>
          <text>
            <paragraph>Adapalene USP, 0.1% (retinoid)
 
  <footnote ID="K276">read consumer information leaflet</footnote>
            </paragraph>
          </text>
          <effectiveTime value="20240723"/>
        </section>
      </component>
      <component>
        <section>
          <id root="3e515a45-7c47-1e08-e063-6294a90a9621"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Acne treatment</paragraph>
          </text>
          <effectiveTime value="20240723"/>
        </section>
      </component>
      <component>
        <section>
          <id root="3e515a45-7c48-1e08-e063-6294a90a9621"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Use</title>
          <text>
            <list listType="unordered" styleCode="Disc">
              <item>For the treatment of acne</item>
            </list>
          </text>
          <effectiveTime value="20240723"/>
        </section>
      </component>
      <component>
        <section>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">For external use only</content>
            </paragraph>
          </text>
          <effectiveTime value="20240723"/>
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              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <title>Do not use</title>
              <text>
                <list listType="unordered" styleCode="Disc">
                  <item>on damaged skin (cuts, abrasions, eczema, sunburn)</item>
                  <item>if you are allergic to adapalene or any of the ingredients in this product.</item>
                </list>
              </text>
              <effectiveTime value="20240723"/>
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              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">If pregnant or breast-feeding, </content>ask a doctor before use.
 </paragraph>
              </text>
              <effectiveTime value="20240723"/>
            </section>
          </component>
          <component>
            <section>
              <id root="3e515a45-7c4c-1e08-e063-6294a90a9621"/>
              <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" styleCode="Disc">
                  <item>limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors</item>
                  <item>do not wax to remove hair in areas where the product has been applied</item>
                  <item>during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe</item>
                  <item>irritation (redness, itching, dryness, burning) is more likely to occur:
  
   <list listType="unordered" styleCode="Disc">
                      <item>in the first few weeks of use</item>
                      <item>if using more than one topical acne medication at a time</item>
                      <item>but irritation usually lessens with continued use of this product</item>
                    </list>
                  </item>
                  <item>it may take up to 3 months of once daily use to see results</item>
                  <item>avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.</item>
                  <item>wash hands after use</item>
                </list>
              </text>
              <effectiveTime value="20240723"/>
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            <section>
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              <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
              <title>Stop use and ask doctor if</title>
              <text>
                <list listType="unordered" styleCode="Disc">
                  <item>you become pregnant, or are planning to become pregnant, while using the product</item>
                  <item>you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)</item>
                  <item>irritation becomes severe</item>
                  <item>you see no improvement after 3 months of once daily use</item>
                </list>
              </text>
              <effectiveTime value="20240723"/>
            </section>
          </component>
          <component>
            <section ID="id_link_3e64378b-e333-9786-e063-6294a90a6102">
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              <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Keep out of reach of children. </content>If swallowed, get medical help or contact a Poison Control Center right away.
 </paragraph>
              </text>
              <effectiveTime value="20240723"/>
            </section>
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <paragraph>
              <content styleCode="bold">Adults and children 12 years of age and older:</content>
            </paragraph>
            <list listType="unordered" styleCode="Disc">
              <item>use 
   <content styleCode="bold">once </content>daily
  </item>
              <item>clean the skin gently and pat dry before applying the product</item>
              <item>cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.</item>
              <item>do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.</item>
            </list>
            <paragraph>
              <content styleCode="bold">Children under 12 years of age: </content>ask a doctor
 </paragraph>
          </text>
          <effectiveTime value="20240723"/>
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          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>Other information</title>
          <text>
            <list listType="unordered" styleCode="Disc">
              <item>
                <content styleCode="bold">TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.</content>
              </item>
              <item>
                <content styleCode="bold">store at 20° to 25°C (68° to 77°F) </content>[see USP Controlled Room Temperature].
  </item>
              <item>protect from freezing</item>
            </list>
          </text>
          <effectiveTime value="20240723"/>
        </section>
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        <section>
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.</paragraph>
          </text>
          <effectiveTime value="20240723"/>
        </section>
      </component>
      <component>
        <section>
          <id root="3e515a45-7c52-1e08-e063-6294a90a9621"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions?</title>
          <text>
            <paragraph>
              <content styleCode="bold">1-800-910-6874</content>
            </paragraph>
          </text>
          <effectiveTime value="20240723"/>
        </section>
      </component>
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          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <text>
            <paragraph>Distributed by Target Corporation
  <br/>
Minneapolis, MN 55403
  <br/>
              <content styleCode="bold">Made in Canada</content>
              <br/>
TM &amp; ©2025 Target Brands, Inc.
 </paragraph>
            <paragraph>NDC 82442-105-01</paragraph>
            <paragraph/>
          </text>
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        </section>
      </component>
      <component>
        <section ID="id_link_3e515fff-a0e0-4820-e063-6294a90ac347">
          <id root="3e515fff-a0df-4820-e063-6294a90ac347"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 15 g Tube Carton</title>
          <text>
            <paragraph>Adapalene
  <br/>
Gel USP,
  <br/>
0.1%
  <br/>
Acne Treatment
 </paragraph>
            <list listType="unordered" styleCode="Disc">
              <item>Previously available by
   <br/>
	prescription only
  </item>
              <item>Once daily topical retinoid*</item>
              <item>FDA approved</item>
            </list>
            <paragraph>Dermatologist
  <br/>
Tested
 </paragraph>
            <paragraph>up&amp;up 
  <sub>™</sub>
            </paragraph>
            <paragraph>*Read consumer information
  <br/>
leaflet before use
 </paragraph>
            <paragraph>NET WT 0.5 OZ (15 g)</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="img_3e516361-a869-ff1c-e063-6394a90aeb7a"/>
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          </text>
          <effectiveTime value="20250908"/>
          <component>
            <observationMedia ID="img_3e516361-a869-ff1c-e063-6394a90aeb7a">
              <text>Carton</text>
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                <reference value="Target Adapalene Gel 0.1 15g Carton.jpg"/>
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