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   <title>Oxytrol<sup>®</sup> For Women</title>
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                        <name>Oxytrol For Women</name>
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                              <name>oxybutynin</name>
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                              <numerator value="3.9" unit="mg"/>
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                                    <name>oxybutynin</name>
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               <text>
                  <paragraph>
                     <content styleCode="bold italics">Drug Facts</content>
                  </paragraph>
               </text>
               <effectiveTime value="20130726"/>
            </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 (in each patch [transdermal  system])</title>
               <text>
                  <paragraph>Oxybutynin 3.9 mg/day</paragraph>
               </text>
               <effectiveTime value="20130726"/>
            </section>
         </component>
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               <id root="eb39ac54-5a1b-4910-a568-a7104175024a"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>Overactive bladder treatment</paragraph>
               </text>
               <effectiveTime value="20130726"/>
            </section>
         </component>
         <component>
            <section>
               <id root="6468b1ae-eb6d-4303-bc2b-723a799b4c5b"/>
               <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="square">
                     <item>treats overactive bladder in women</item>
                     <item>you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at <content styleCode="bold">least 3 months</content>
                        <list listType="unordered" styleCode="Square">
                           <item>urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours)</item>
                           <item>urinary urgency (a strong need to urinate right away)</item>
                           <item>urinary incontinence (leaking or wetting yourself if you cannot control the urge to urinate)</item>
                        </list>
                     </item>
                     <item>non-drug therapies may also help you (see the consumer information leaflet inside the package)</item>
                  </list>
               </text>
               <effectiveTime value="20130813"/>
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               <title>Warnings</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">For external use only</content>
                  </paragraph>
                  <paragraph>Frequent urination can also be caused by:</paragraph>
                  <list listType="unordered" styleCode="square">
                     <item>urinary tract infections (UTI)</item>
                     <item>diabetes</item>
                     <item>early pregnancy</item>
                     <item>other more serious conditions</item>
                  </list>
                  <paragraph>If you think you might have one of these conditions, it is important to see your doctor before use.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Sleepiness, dizziness, and blurry vision may occur.  Do not drive or operate machinery until you know how the patch affects you.</content>
                  </paragraph>
               </text>
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                     <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Do not use</content> if you</paragraph>
                        <list listType="unordered" styleCode="square">
                           <item>
                              <content styleCode="bold">have any of these symptoms, which could be the sign of a UTI or other serious condition. </content>
                           </item>
                        </list>
                        <paragraph>
                           <content styleCode="bold">See your doctor as soon as possible if you have:</content>
                        </paragraph>
                        <list listType="unordered">
                           <item>
                              <caption> </caption>
                              <list listType="unordered" styleCode="square">
                                 <item>pain or burning when urinating.  These symptoms may also be accompanied by a fever or chills</item>
                                 <item>blood in your urine</item>
                                 <item>unexplained lower back or side pain</item>
                                 <item>urine that is cloudy, or foul-smelling</item>
                              </list>
                           </item>
                        </list>
                        <list listType="unordered" styleCode="square">
                           <item>are male.  Your symptoms may be due to a more serious condition.</item>
                           <item>are under the age of 18.  It is not known if it works or is safe in children.</item>
                           <item>only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence.  This product will not work for that condition.</item>
                           <item>have been told by a doctor you have urinary retention (are not able to empty your bladder)</item>
                           <item>have been told by a doctor you have gastric retention (your stomach empties slowly after a meal)</item>
                           <item>have glaucoma</item>
                           <item>are allergic to oxybutynin</item>
                        </list>
                     </text>
                     <effectiveTime value="20130813"/>
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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="square">
                           <item>symptoms of diabetes, such as:<list listType="unordered" styleCode="square">
                                 <item>excessive thirst</item>
                                 <item>extreme hunger</item>
                              </list>
                           </item>
                           <item>unexplained weight loss</item>
                           <item>liver or kidney disease</item>
                        </list>
                     </text>
                     <effectiveTime value="20130726"/>
                  </section>
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                     <id root="83aebc44-f4f3-4ffd-a2e4-f34d108d996e"/>
                     <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
                     <title>Ask a doctor or pharmacist before use if you are</title>
                     <text>
                        <list listType="unordered" styleCode="square">
                           <item>taking a prescription medication for overactive bladder</item>
                           <item>taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision</item>
                           <item>taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example ketoconazole, itraconazole)</item>
                        </list>
                     </text>
                     <effectiveTime value="20130813"/>
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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="square">
                           <item>you may have itching, rash or redness where the patch was placed</item>
                           <item>drinking alcohol may increase sleepiness</item>
                        </list>
                     </text>
                     <effectiveTime value="20130726"/>
                  </section>
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                     <id root="971dbc63-afcb-4f14-8ab8-df4ab4a120d7"/>
                     <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>you are not able to empty your bladder (urinary retention)</item>
                           <item>condition worsens, or if new symptoms appear</item>
                           <item>condition does not improve after 2 weeks of use</item>
                           <item>you have an allergic reaction to this product</item>
                           <item>if you have severe redness, itchiness or blistering at the site of application</item>
                        </list>
                     </text>
                     <effectiveTime value="20130813"/>
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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 breastfeeding, ask a health professional before use.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20130726"/>
                  </section>
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                     <id root="d68abf2c-78e4-4168-bdbf-38e4d6d881e9"/>
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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="20130726"/>
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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>women 18 years of age and older</paragraph>
                  <paragraph>
                     <content styleCode="bold">How to use the patch:</content>
                  </paragraph>
                  <list listType="unordered" styleCode="square">
                     <item>open 1 pouch and apply patch immediately to a clean, dry and smooth area of skin on your abdomen, hips or buttocks.  Do not put the patch on oily, damaged (cut or scraped), or irritated (rashes) skin.  Do not put the patch on skin with oils, lotions or powders because that could keep the patch from sticking to your skin.</item>
                     <item>wear patch under clothing, do not expose the patch to sunlight</item>
                     <item>do not cut the patch into smaller pieces</item>
                     <item>wear only 1 patch at a time for 4 days in a row</item>
                     <item>after 4 days, remove the used patch and apply a new one</item>
                     <item>change the patch every 4 days for as long as you use this product</item>
                     <item>each time you put on a new patch, change the place where you put it (i.e., <content styleCode="italics">abdomen, hips or buttocks</content>)</item>
                     <item>if a patch falls off and you cannot press it back onto your skin, use a new patch</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">How to dispose of a used patch:</content>
                  </paragraph>
                  <list listType="unordered" styleCode="square">
                     <item>when you take off a used patch, fold it in half with the sticky sides together</item>
                     <item>throw it away so that it cannot be worn or swallowed by another person, especially a child, or a pet</item>
                  </list>
               </text>
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               <title>Other information</title>
               <text>
                  <list listType="unordered" styleCode="square">
                     <item>product comes in individual sealed pouches, do not use if pouch is torn or opened</item>
                     <item>store between 20° to 25° C (68° to 77° F)</item>
                     <item>protect from moisture and humidity</item>
                     <item>do not store outside the sealed pouch</item>
                  </list>
               </text>
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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>Acrylic adhesive, polyester/ethylene-vinyl acetate film, siliconized polyester film, and triacetin</paragraph>
               </text>
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               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Question or comments?</title>
               <text>
                  <paragraph>Call toll-free <content styleCode="bold">1-888-OXYTROL (1-888-699-8765)</content> between 8:00 AM and 5:00 PM Central Standard Time. Monday through Friday</paragraph>
               </text>
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               <text>
                  <paragraph>Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA,<br/> a subsidiary of Merck &amp; Co., Inc., Whitehouse Station, NJ USA.</paragraph>
               </text>
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               <title>PRINCIPAL DISPLAY PANEL - 1 Patch Pouch</title>
               <text>
                  <paragraph>FOLD AT LINE<br/>					TEAR AT ARROW</paragraph>
                  <paragraph>NDC 11523-4311-1</paragraph>
                  <paragraph>
                     <content styleCode="bold">Full Prescription Strength</content>
                  </paragraph>
                  <paragraph>OXYBUTYNIN <content styleCode="bold">TRANSDERMAL SYSTEM 3.9 mg/day<br/>						Overactive Bladder Treatment</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Oxytrol<sup>®</sup>
                     </content>
                     <br/>						FOR WOMEN</paragraph>
                  <paragraph>
                     <content styleCode="bold italics">RELIEF FROM<br/>						Overactive Bladder</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Product comes in individual sealed pouches, do not use if pouch is torn or opened.</content>
                     <br/>						Store between 20° to 25°C (68° to 77°F). Protect from moisture and humidity. Do not store outside the sealed pouch.</paragraph>
                  <paragraph>
                     <content styleCode="bold">1 </content>Patch Treats for<br/>
                     <content styleCode="bold">4</content> Days/<content styleCode="bold">4</content> Nights</paragraph>
                  <paragraph>
                     <content styleCode="bold">Contents:<br/>1<br/>PATCH<br/>(Transdermal System)</content>
                  </paragraph>
                  <renderMultiMedia referencedObject="MM1"/>
               </text>
               <effectiveTime value="20130813"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>PRINCIPAL DISPLAY PANEL - 1 Patch Pouch</text>
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               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 4 Patch Carton</title>
               <text>
                  <paragraph>
                     <content styleCode="bold italics">New!</content>
                  </paragraph>
                  <paragraph>NDC 11523-4322-4</paragraph>
                  <paragraph>
                     <content styleCode="bold">Full Prescription Strength</content>
                  </paragraph>
                  <paragraph>OXYBUTYNIN <content styleCode="bold">TRANSDERMAL SYSTEM 3.9 mg/day</content>
                     <br/>Overactive Bladder Treatment</paragraph>
                  <paragraph>
                     <content styleCode="bold">Oxytrol</content>
                     <sup>®</sup>
                     <br/>FOR WOMEN</paragraph>
                  <paragraph>
                     <content styleCode="bold italics">RELIEF FROM <br/>Overactive Bladder</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">1 Patch Treats for<br/>4 Days/4 Nights</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">4<br/>PATCHES<br/>(Transdermal Systems)<br/>16-Day Supply</content>
                  </paragraph>
                  <renderMultiMedia referencedObject="MM2"/>
               </text>
               <effectiveTime value="20130813"/>
               <component>
                  <observationMedia ID="MM2">
                     <text>Principal Display Panel - 4 Patch Carton</text>
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                        <reference value="oxytrol-02.jpg"/>
                     </value>
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