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  <title>Miconazole Nitrate</title>
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                <name>Miconazole Nitrate</name>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient</title>
          <text>
            <paragraph>Miconazole nitrate USP 2% (100 mg in each applicatorful)</paragraph>
          </text>
          <effectiveTime value="20200122"/>
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          <id root="f562b57d-6598-93fa-e053-2995a90ae3e0"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Vaginal antifungal</paragraph>
          </text>
          <effectiveTime value="20200122"/>
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        <section>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <list listType="unordered" styleCode="Disc">
              <item>treats vaginal yeast infections</item>
              <item>relieves external itching and irritation due to a vaginal yeast infection</item>
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          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">For vaginal use only</content>
            </paragraph>
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                <paragraph>
                  <content styleCode="bold">Do not use if you have never had a vaginal yeast infection diagnosed by a doctor</content>
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              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title>Ask a doctor before use if you have</title>
              <text>
                <list listType="unordered" styleCode="Disc">
                  <item>
                    <content styleCode="bold">vaginal itching and discomfort for the first time</content>
                  </item>
                  <item>
                    <content styleCode="bold">lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.</content>
                  </item>
                  <item>vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.</item>
                  <item>been exposed to the human immunodeficiency virus (HIV) that causes AIDS</item>
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              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor or pharmacist before use if you are</content> taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
        

 </paragraph>
              </text>
              <effectiveTime value="20200122"/>
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              <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>do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).</item>
                  <item>do not have vaginal intercourse</item>
                  <item>mild increase in vaginal burning, itching or irritation may occur</item>
                  <item>if you do not get complete relief ask a doctor before using another product</item>
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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 a doctor if</title>
              <text>
                <list listType="unordered" styleCode="Disc">
                  <item>
                    <content styleCode="bold">symptoms do not get better in 3 days </content>
                  </item>
                  <item>
                    <content styleCode="bold">symptoms last more than 7 days</content>
                  </item>
                  <item>
                    <content styleCode="bold">you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.</content>
                  </item>
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              <effectiveTime value="20200122"/>
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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 health professional before use.
        

 </paragraph>
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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 (1-800-222-1222) right away.
        

 </paragraph>
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          <title>Directions</title>
          <text>
            <list listType="unordered" styleCode="Disc">
              <item>before using this product read the enclosed consumer information leaflet for complete directions and information</item>
              <item>adults and children 12 years of age and over:
        
  
   <list listType="unordered" styleCode="Disc">
                  <item>
                    <content styleCode="bold">applicator:</content> insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
         
   
    </item>
                  <item>use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.</item>
                </list>
              </item>
              <item>
                <content styleCode="bold">children under 12 years of age: ask a doctor</content>
              </item>
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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>do not purchase if carton is opened</item>
              <item>do not use if seal over tube opening has been punctured or is not visible</item>
              <item>store at 20° to 25°C (68° to 77°F)</item>
              <item>see carton or tube crimp for lot number and expiration date</item>
            </list>
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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>benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.</paragraph>
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          <effectiveTime value="20200122"/>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions?</title>
          <text>
            <paragraph>call 
       
 
  <content styleCode="bold">1-866-923-4914</content>
            </paragraph>
          </text>
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          <text>
            <paragraph>Distributed by:
       
 
  <br/>
              <content styleCode="bold">Taro Pharmaceuticals U.S.A., Inc.</content>
              <br/>Hawthorne, NY 10532
      

 </paragraph>
          </text>
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