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   <title>WOMEN'S Rogaine 
 <sup>®</sup> UNSCENTED
</title>
   <effectiveTime value="20230104"/>
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            <name>Johnson &amp; Johnson Consumer Inc.</name>
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                        <name>Womens Rogaine Unscented</name>
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                           <genericMedicine>
                              <name>Minoxidil</name>
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                              <name>MINOXIDIL</name>
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                                    <name>MINOXIDIL</name>
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                                          <low value="20100801"/>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Drug Facts</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20161219"/>
            </section>
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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>Minoxidil  2% w/v</paragraph>
               </text>
               <effectiveTime value="20161219"/>
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            <section>
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               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>Hair regrowth treatment</paragraph>
               </text>
               <effectiveTime value="20161219"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de58-8460-e053-2995a90af873"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Use</title>
               <text>
                  <paragraph>to regrow hair on the scalp </paragraph>
               </text>
               <effectiveTime value="20161219"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de59-8460-e053-2995a90af873"/>
               <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>
                  <paragraph>
                     <content styleCode="bold">Flammable:</content> Keep away from fire or flame
      

 </paragraph>
               </text>
               <effectiveTime value="20161219"/>
               <component>
                  <section>
                     <id root="ee3521ea-de5a-8460-e053-2995a90af873"/>
                     <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
                     <title>Do not use if</title>
                     <text>
                        <list listType="unordered" styleCode="Square">
                           <item>your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you</item>
                           <item>you have no family history of hair loss</item>
                           <item>your hair loss is sudden and/or patchy</item>
                           <item>your hair loss is associated with childbirth</item>
                           <item>you do not know the reason for your hair loss</item>
                           <item>you are under 18 years of age.  Do not use on babies and children.</item>
                           <item>your scalp is red, inflamed, infected, irritated, or painful</item>
                           <item>you use other medicines on the scalp</item>
                        </list>
                     </text>
                     <effectiveTime value="20161219"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="ee3521ea-de5b-8460-e053-2995a90af873"/>
                     <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Ask a doctor before use if you have</content> heart disease
        

 </paragraph>
                     </text>
                     <effectiveTime value="20161219"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="ee3521ea-de5c-8460-e053-2995a90af873"/>
                     <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="Square">
                           <item>do not apply on other parts of the body</item>
                           <item>avoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.</item>
                           <item>some people have experienced changes in hair color and/or texture</item>
                           <item>it takes time to regrow hair.  You may need to use this product 2 times a day for at least 4 months before you see results.</item>
                           <item>the amount of hair regrowth is different for each person.  This product will not work for everyone.</item>
                        </list>
                     </text>
                     <effectiveTime value="20161219"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="ee3521ea-de5d-8460-e053-2995a90af873"/>
                     <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="Square">
                           <item>chest pain, rapid heartbeat, faintness, or dizziness occurs</item>
                           <item>sudden, unexplained weight gain occurs</item>
                           <item>your hands or feet swell</item>
                           <item>scalp irritation or redness occurs</item>
                           <item>unwanted facial hair growth occurs</item>
                           <item>you do not see hair regrowth in 4 months</item>
                        </list>
                     </text>
                     <effectiveTime value="20161219"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="ee3521ea-de5e-8460-e053-2995a90af873"/>
                     <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">May be harmful if used when pregnant or breast-feeding.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20161219"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="ee3521ea-de5f-8460-e053-2995a90af873"/>
                     <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="20161219"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de60-8460-e053-2995a90af873"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>apply one mL with dropper 2  times a day directly onto the scalp in the hair loss area</item>
                     <item>using more or more often will not improve results </item>
                     <item>continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again</item>
                  </list>
               </text>
               <effectiveTime value="20161219"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de61-8460-e053-2995a90af873"/>
               <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="Square">
                     <item>see hair loss pictures on side of this carton</item>
                     <item>before use, read all information on carton and enclosed booklet</item>
                     <item>keep the carton.  It contains important information.</item>
                     <item>In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth).  This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).</item>
                     <item>store at controlled room temperature 20° to 25° C (68° to 77° F)</item>
                  </list>
               </text>
               <effectiveTime value="20161219"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de62-8460-e053-2995a90af873"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredients</title>
               <text>
                  <paragraph>alcohol, propylene glycol, purified water</paragraph>
               </text>
               <effectiveTime value="20161219"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de63-8460-e053-2995a90af873"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions?</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>call toll-free 
        
  
   <content styleCode="bold">800-764-2463</content> or 
        
  
   <content styleCode="bold">215-273-8755</content> (collect)
       
 
  </item>
                     <item>visit www.rogaine.com</item>
                  </list>
               </text>
               <effectiveTime value="20161219"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ee3521ea-de64-8460-e053-2995a90af873"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">#1 DERMATOLOGIST
        
  
   <br/>RECOMMENDED BRAND
       
 
  </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">WOMEN'S
        
  
   <br/>Rogaine
        
  
   <sup>®</sup>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">2% Minoxidil
        
  
   <br/>Topical Solution
       
 
  </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Hair Regrowth
        
  
   <br/>Treatment
       
 
  </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">REACTIVATES
        
  
   <br/>HAIR FOLLICLES
        
  
   <br/>TO STIMULATE
        
  
   <br/>REGROWTH
       
 
  </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CLINICALLY PROVEN
        
  
   <br/>TO HELP REGROW HAIR
       
 
  </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Topical Solution</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">UNSCENTED</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">One Month Supply
        
  
   <br/>One 60 mL (2 fl oz) Bottle
       
 
  </content>
                  </paragraph>
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               </text>
               <effectiveTime value="20161219"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton</text>
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                        <reference value="womens-01.jpg"/>
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