<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="4a8e4d79-d374-d70e-e063-6394a90a643d"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>981 Medline Hydrogen Peroxide Solution</title>
   <effectiveTime value="20260211"/>
   <setId root="4593f51a-9bcb-4149-9ce4-4f62183fd3dd"/>
   <versionNumber value="12"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="025460908"/>
            <name>Medline Industries, LP</name>
            <assignedEntity>
               <assignedOrganization>
                  <id root="1.3.6.1.4.1.519.1" extension="025460908"/>
                  <name>Medline Industries, LP</name>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="4a8e760b-d32c-18e7-e063-6394a90a3fbf"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20260211"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="53329-981" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Hydrogen Peroxide<suffix>First Aid Antiseptic</suffix>
                        </name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Hydrogen Peroxide</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>WATER</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mL" value="3"/>
                              <denominator unit="mL" value="100"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="BBX060AN9V" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>HYDROGEN PEROXIDE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="BBX060AN9V" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>HYDROGEN PEROXIDE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="473" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="53329-981-06" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic>
                                 <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                              </characteristic>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20070101"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="3780" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="53329-981-25" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43196" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="JUG"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic>
                                 <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                              </characteristic>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20070101"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="M003" root="2.16.840.1.113883.3.9421"/>
                           <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20070101"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="i4i_OTC_Active_Ingredient_id_b2bc71aa-a053-469c-bb08-250855eaf870">
               <id root="efe08cd3-6aba-7237-e053-2995a90a1583"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">
                     <content styleCode="italics">Active ingredient</content>
                  </content>
               </title>
               <text>
                  <paragraph>Hydrogen peroxide (stabilized) 3%</paragraph>
               </text>
               <effectiveTime value="20120309"/>
            </section>
         </component>
         <component>
            <section ID="i4i_OTC_Purpose_id_19685bed-d749-49e6-9fec-86434b3a2d21">
               <id root="efe09258-dec3-2bab-e053-2995a90aea98"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>
                  <content styleCode="italics">
                     <content styleCode="bold">Purpose</content>
                  </content>
               </title>
               <text>
                  <paragraph>First Aid Antiseptic
  <br/>
Oral debriding agent
 </paragraph>
               </text>
               <effectiveTime value="20070101"/>
            </section>
         </component>
         <component>
            <section ID="i4i_indications_id_d2ccac93-4b2e-466a-a0c6-4b3b818e3350">
               <id root="efe09258-dec4-2bab-e053-2995a90aea98"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="bold">
                     <content styleCode="italics">Uses</content>
                  </content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>first aid to help prevent the risk of infection in minor cuts, scrapes and burns</item>
                     <item>aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth</item>
                  </list>
               </text>
               <effectiveTime value="20120309"/>
            </section>
         </component>
         <component>
            <section ID="i4i_warnings_id_a1f256b7-6e30-4e02-849f-03496c30adef">
               <id root="efe07cd9-7394-d557-e053-2995a90a17a1"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="bold">
                     <content styleCode="italics">Warnings</content>
                  </content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">For external use only.</content>
                     <br/>
                  </paragraph>
               </text>
               <effectiveTime value="20150924"/>
               <component>
                  <section ID="id_link_349d584a-fe59-4f5d-e054-00144ff88e88">
                     <id root="349d584a-fe58-4f5d-e054-00144ff88e88"/>
                     <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">
                           <item>in the eyes or apply over large areas of the body</item>
                           <item>longer than 1 week</item>
                        </list>
                     </text>
                     <effectiveTime value="20150806"/>
                  </section>
               </component>
               <component>
                  <section ID="i4i_OTC_When_Using_id_13d6b330-bf86-466a-8455-15ad25613490">
                     <id root="349d69c9-1c85-5ddd-e054-00144ff8d46c"/>
                     <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>
                        <paragraph>deep or puncture wounds, animal bites, or serious burns</paragraph>
                     </text>
                     <effectiveTime value="20150924"/>
                  </section>
               </component>
               <component>
                  <section ID="i4i_OTC_Stop_Use_id_8f2eeead-0d48-455a-aea0-2a7511eafa91">
                     <id root="349d584a-fe62-4f5d-e054-00144ff88e88"/>
                     <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">
                           <item>condition persists or gets worse</item>
                           <item>sore mouth symptoms do not improve in 7 days</item>
                           <item>irritation, pain, or redness persists or worsens</item>
                           <item>swelling, rash, or fever develops</item>
                        </list>
                     </text>
                     <effectiveTime value="20150924"/>
                  </section>
               </component>
               <component>
                  <section ID="i4i_OTC_Keep_Away_Children_id_ea308894-ec53-45f0-af58-2b97f28b7c4e">
                     <id root="349d0947-0f66-4ab5-e054-00144ff8d46c"/>
                     <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
                     <title>Keep out of reach of children.</title>
                     <text>
                        <paragraph>If swallowed, get medical help or contact a Poison Control Center right away.</paragraph>
                     </text>
                     <effectiveTime value="20120309"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="i4i_dosage_admin_id_a1f72578-91d9-44b4-9518-be3b33a87cbb">
               <id root="41ed8a8a-ccd7-7a97-e063-6394a90add6e"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="bold">
                     <content styleCode="italics">Directions</content>
                  </content>
               </title>
               <text>
                  <paragraph>First aid antiseptic:</paragraph>
                  <list listType="unordered">
                     <item>Clean the affected area</item>
                     <item>Apply a small amount of product on the area 1 to 3 times a day</item>
                     <item>May be covered with a sterile bandage</item>
                     <item>If bandaged, let dry first</item>
                  </list>
                  <paragraph/>
                  <paragraph>Oral debriding agent: adults, children over 2 years of age:</paragraph>
                  <list listType="unordered">
                     <item>mix with an equal amount of water</item>
                     <item>swish around in the mouth over the affected area for at least 1 minute, then spit out</item>
                     <item>use up to 4 times daily after meals and at bedtime</item>
                     <item>children under 12 years of age should be supervised in the use</item>
                     <item>children under 2 years of age: consult a dentist, doctor</item>
                  </list>
               </text>
               <effectiveTime value="20150924"/>
            </section>
         </component>
         <component>
            <section ID="i4i_storage_id_568cc3b1-3cc6-4779-8ed9-dd31efacea4f">
               <id root="efe08cd3-6abc-7237-e053-2995a90a1583"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>
                  <content styleCode="bold">
                     <content styleCode="italics">Other information</content>
                  </content>
               </title>
               <text>
                  <paragraph>Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.</paragraph>
               </text>
               <effectiveTime value="20150924"/>
            </section>
         </component>
         <component>
            <section ID="i4i_inactive_ingredients_id_b799bc09-699b-4ab0-a8e3-4d951dbd6dca">
               <id root="efe09258-dec7-2bab-e053-2995a90aea98"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">
                     <content styleCode="italics">Inactive ingredients</content>
                  </content>
               </title>
               <text>
                  <paragraph>purified water</paragraph>
               </text>
               <effectiveTime value="20070101"/>
            </section>
         </component>
         <component>
            <section ID="id_link_efe07cd9-7392-d557-e053-2995a90a17a1">
               <id root="41ed8999-beeb-4876-e063-6294a90aeacf"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Manufacturing Information</title>
               <text>
                  <paragraph>www.medline.com</paragraph>
                  <paragraph>Made in US with US and foreign components</paragraph>
                  <paragraph>for Medline Industries, LP,
  <br/>
Three Lakes Drive, Northfield, IL 60093 USA
  <br/>
1-800-MEDLINE
 </paragraph>
                  <paragraph>
                     <br/>
REF: MDS098001Z
 </paragraph>
               </text>
               <effectiveTime value="20170901"/>
            </section>
         </component>
         <component>
            <section ID="i4i_Principal_display_panel_id_0b2c19dd-fe74-40cd-9ce4-3504f13cf9f3">
               <id root="41ecebe8-c8e2-cf7b-e063-6394a90af985"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Package Label</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="img_41ecf204-394a-d419-e063-6294a90ad955"/>
                     <renderMultiMedia referencedObject="img_41ecf2c2-1cfd-4a0a-e063-6294a90acdc0"/>
                  </paragraph>
               </text>
               <effectiveTime value="20170901"/>
               <component>
                  <observationMedia ID="img_41ecf204-394a-d419-e063-6294a90ad955">
                     <text>package front label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="53329-981_MDS098001Z_label front.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="img_41ecf2c2-1cfd-4a0a-e063-6294a90acdc0">
                     <text>Package back label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="53329-981_MDS098001Z_label back.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>