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  <title>Fungicure Manicure Pedicure Gel</title>
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                    <name>Clotrimazole</name>
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          <title>Active Ingredient</title>
          <text>
            <paragraph>Clotrimazole 1% w/w
  <br/>
            </paragraph>
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          <title>Purpose</title>
          <text>
            <paragraph>Antifungal</paragraph>
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          <effectiveTime value="20160711"/>
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          <title>Uses</title>
          <text>
            <paragraph>For the cure of most</paragraph>
            <list listType="unordered">
              <item>ringworm (tinea corporis)</item>
              <item>athlete's foot (tinea pedis)</item>
            </list>
            <paragraph>For relief of 
       
 
  <br/>
            </paragraph>
            <list listType="unordered">
              <item>itching</item>
              <item>scaling</item>
              <item>cracking</item>
              <item>burning</item>
              <item>redness</item>
              <item>soreness</item>
              <item>irritation</item>
              <item>discomforts which may accompany these conditions.</item>
            </list>
          </text>
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          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">For external use only
        
  
   <br/>
              </content>
            </paragraph>
            <paragraph>
              <br/>
              <content styleCode="bold"/>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <br/>
              </content>
            </paragraph>
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            <paragraph>
              <content styleCode="bold">Ask a doctor before use</content> on children under 2 years of age.
      

 </paragraph>
          </text>
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            <paragraph>
              <content styleCode="bold">When using this product</content> avoid contact with the eyes.
      

 </paragraph>
          </text>
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          <title>Stop use and ask a doctor if</title>
          <text>
            <br/>
            <list listType="unordered">
              <item>Irritation occurs</item>
              <item>There is no improvement within 4 weeks.</item>
            </list>
          </text>
          <effectiveTime value="20160711"/>
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          <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="20160711"/>
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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>
            <list listType="unordered">
              <item>Read all package directions and warnings before use.</item>
              <item>Use only as directed.</item>
              <item>Clean the affected area with soap and warm water and dry thoroughly.</item>
              <item>Apply a thin layer of Fungicure over the affected area twice daily (morning and night), or as directed by a doctor.</item>
              <item>
                <content styleCode="bold">This product is not effective on scalp or nails.</content>
              </item>
              <item>Avoid applying to severely cracked or irritated areas.</item>
              <item>For athlete's foot and ringworm, use daily for 4 weeks.  If condition persists longer, consult a doctor.</item>
              <item>For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.</item>
              <item>Intended for use by normally healthy adults only.</item>
              <item>Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.</item>
              <item>Supervise children in the use of this product.</item>
            </list>
          </text>
          <effectiveTime value="20181015"/>
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          <code code="34076-0" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR PATIENTS SECTION"/>
          <title>Other information</title>
          <text>
            <list listType="unordered">
              <item>FUNGICURE may be applied to exposed nail-beds, cuticles, around nail edges and under nail tips where reachable with its precision QuickBrush applicator. This product is not intended to, nor will it, penetrate hard nail surfaces.</item>
              <item>While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use Fungicure until satisfactory results are obtained.</item>
              <item>You may report serious side effects to the phone number provided under 
   <content styleCode="italics">Questions?</content> below.
  </item>
            </list>
          </text>
          <effectiveTime value="20181015"/>
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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>Hydroxypropylcellulose and isopropyl alcohol.</paragraph>
          </text>
          <effectiveTime value="20160711"/>
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          <id root="78484129-09ac-06b3-e053-2991aa0ac8fd"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <text>
            <paragraph>
              <content styleCode="bold">Questions? 1-800-792-2582</content>
            </paragraph>
          </text>
          <effectiveTime value="20160711"/>
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      <component>
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          <code code="42230-3" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PATIENT PACKAGE INSERT SECTION"/>
          <title>Fungicure Maximum Strength Liquid Gel Insert</title>
          <text>
            <paragraph>
              <content styleCode="bold">Maximum Strength FUNGICURE </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Manicure &amp; Pedicure Anti-Fungal Treatment </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Professional Formula Liquid Gel</content>
            </paragraph>
            <paragraph/>
            <list listType="unordered">
              <item>Kills ugly fungus for healthy looking fingers &amp; toes</item>
              <item>Odor free &amp; instant dry</item>
              <item>Liquid Gel locks onto site of infection</item>
            </list>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">The Manicure &amp; Pedicure Fungi Specialist</content>
            </paragraph>
            <paragraph/>
            <paragraph>Maintaining the appearance of your manicure and pedicure requires more than cosmetics. Many manicure procedures can enhance the risk of fungal infection, and certain types of artificial nails can trap moisture and fungi and create a perfect environment for fungus to grow and spread. Cutting cuticles can also create opportunities for fungal infections. When you promptly treat fungal infections on cuticles and nearby skin surfaces, you reduce the risk of the infections spreading.</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Fungicure Manicure &amp; Pedicure Liquid Gel</content> is a maximum strength anti-fungal, specifically formulated for those with professionally or home-manicured, pedicured or artificial nails. 
  <content styleCode="bold">Fungicure's</content> precision QuickBrush applicator allows for easy application on hard to reach infections, including under nail tips.
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">WHAT IS FUNGUS INFECTION OF THE FINGER AND TOES?</content>
            </paragraph>
            <paragraph>Common topical fungus infections of the finger and toes are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which thrive in dark, moist conditions. Using small breaches in the skin's surface, these organisms can cause infection by contact with infected surfaces, animals or people. Once infection starts, spreading may occur. For example, infected fingers and toes may infect other fingers and toes. Although such infections often develop slowly, they may be difficult to eliminate if not treated promptly with an effective anti-fungal medicine like 
  <content styleCode="bold">Fungicure.</content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">HOW DO YOU KNOW IF YOU HAVE A TOPICAL FUNGUS INFECTION?</content>
            </paragraph>
            <paragraph>Some topical fungal infections may present themselves on the skin surface as ring-like formations with clear centers; this is commonly called ringworm. Athlete's foot fungus, when in the finger and toe areas, is often characterized by scaling of skin, burning, cracking, itching, and related discomforts. When nails become infected, they may appear to become opaque (cloudy white), thickened, brittle, easily broken, and in some cases, discolored (greenish/brown).</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">UNDERSTANDING AND TREATING A NAIL AREA INFECTION:</content>
            </paragraph>
            <paragraph>Fungal infections of the nail areas are often caused by the same fungi that lead to athlete's foot and ringworm infections elsewhere on the body. These fungi can infect the entire area around the nails including the cuticles, the nail beds, and even the nails themselves. When infected finger/toe nails are intact, over-the-counter topical anti-fungal treatments may not be able to penetrate the nail and kill the fungus; this is why all OTC topical treatments must indicate they are not effective on the nails. However, in instances of advanced infection, the nails often are not intact; they may be missing, cracked open, or lifted away, exposing the infected nail bed. In these instances 
  <content styleCode="bold">FUNGICURE Manicure &amp; Pedicure Liquid Gel</content>, with its powerful anti-fungal formula, can reach and kill nail bed fungus by direct application or related capillary action. 
  <content styleCode="bold">Fungicure </content>cures the infection, allowing the natural regrowth of healthy looking tissue.
 </paragraph>
            <paragraph/>
            <paragraph>NOTE: Fungal infections which are isolated beneath an intact nail or embedded within the nail itself may require consultation from a doctor for proper treatment.</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">HOW FUNGICURE LIQUID GEL WORKS:</content>
            </paragraph>
            <paragraph>MAXIMUM STRENGTH 
  <content styleCode="bold">FUNGICURE Manicure &amp; Pedicure Liquid Gel </content> contains Clotrimazole, a widely recognized anti-fungal ingredient that has been proven to be effective against 6 types of fungi such as E. floccosum, T. mentagrophytes, M. canis, M. gypseum, T. tonsurans and T. rubrum.
 </paragraph>
            <paragraph/>
            <paragraph>When applied as directed, 
  <content styleCode="bold">FUNGICURE Manicure &amp; Pedicure Liquid Gel </content> acts promptly to target, destroy, and prevent the spread of infection by inhibiting the growth and reproduction of fungal cells.
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">PROMPT ACTION AND PROPER TREATMENT:</content>
            </paragraph>
            <paragraph>Early treatment of fungal infections is important. If you suspect that you may have a fungal infection, consult your doctor promptly for advice and proper diagnosis. You may wish to show him/her 
  <content styleCode="bold">FUNGICURE Manicure &amp; Pedicure Liquid Gel </content>and discuss its use. For best results, once treatment is started with 
  <content styleCode="bold">FUNGICURE Manicure &amp; Pedicure Liquid Gel</content>, it is important to carefully follow the treatment instructions on the package until satisfactory results are achieved or advised further by a doctor.
 </paragraph>
            <paragraph/>
            <paragraph>NOTE: Noticeable improvement may be expected within 4 weeks in the case of most ringworm (tinea corporis) and athlete's foot (tinea pedis). Consult your doctor for advice if noticeable improvement is not evident by this time or if condition persists or worsens.</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Active Ingredient:</content> Clotrimazole 1% w/w
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Uses:</content> For the cure of most:
 </paragraph>
            <list listType="unordered">
              <item>ringworm (tinea corporis)</item>
              <item>athlete's foot (tinea pedis).</item>
            </list>
            <paragraph>For relief of:</paragraph>
            <list listType="unordered">
              <item>itching</item>
              <item>scaling</item>
              <item>cracking</item>
              <item>burning</item>
              <item>redness</item>
              <item>soreness</item>
              <item>irritation</item>
              <item>discomforts which may accompany these conditions.</item>
            </list>
            <paragraph>
              <content styleCode="bold">Warnings:</content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">For external use only.</content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Ask a doctor before use</content> on children under 2 years of age.
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">When using this product</content> avoid contact with the eyes.
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Stop use and ask a doctor if</content>
            </paragraph>
            <list listType="unordered">
              <item>irritation occurs</item>
              <item>there is no improvement within 4 weeks.</item>
            </list>
            <paragraph/>
            <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>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Directions:</content>
            </paragraph>
            <list listType="unordered">
              <item>Read all package directions and warnings before use</item>
              <item>Use only as directed</item>
              <item>Clean the affected area with soap and warm water and dry thoroughly.</item>
              <item>Apply a thin layer of 
   <content styleCode="bold">FUNGICURE </content>over the affected area twice daily (morning and night), or as directed by a doctor.
  </item>
              <item>
                <content styleCode="bold">This product is not effective on the scalp or nails.</content>
              </item>
              <item>Avoid applying to severely cracked or irritated areas.</item>
              <item>For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer consult a doctor.</item>
              <item>For athlete's foot: pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.</item>
              <item>Intended for use by normally healthy adults only.</item>
              <item>Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.</item>
              <item>Supervise children in the use of this product.</item>
            </list>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Other Information:</content>
            </paragraph>
            <list listType="unordered">
              <item>
                <content styleCode="bold">Fungicure</content> may be applied to exposed nail-beds, cuticles, around nail edges and under nail tips where reachable with its precision QuickBrush applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces.
  </item>
              <item>While not all finger and toe area fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use 
   <content styleCode="bold">FUNGICURE </content>until satisfactory results are obtained.
  </item>
              <item>You may report serious side effects to the phone number provided under 
   <content styleCode="italics">Questions?</content> below.
  </item>
            </list>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Inactive ingredients:</content> Hydroxypropylcellulose and Isopropyl alcohol.
 </paragraph>
            <paragraph>
              <content styleCode="bold">Questions? 1-800-792-2582</content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">www.Fungicure.com </content>
            </paragraph>
            <paragraph>The active ingredient in 
  <content styleCode="bold">Fungicure</content> has been recognized to be safe and effective by an FDA Expert Advisory Panel, when used as directed.
 </paragraph>
          </text>
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