<?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="2f39c762-bcb8-c030-e063-6294a90a4558"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Good Neighbor Pharmacy Earwax Removal Drops</title>
   <effectiveTime value="20250228"/>
   <setId root="89eac1b0-c700-45b5-8478-da53ace72e16"/>
   <versionNumber value="3"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="007914906"/>
            <name>Amerisource Bergen</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="2f39c8e9-ec25-c4ef-e063-6294a90ab96a"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20250228"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="46122-557" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Good Neighbor Pharmacy Earwax Removal Drops</name>
                        <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>CARBAMIDE PEROXIDE</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="XF417D3PSL" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ANHYDROUS CITRIC ACID</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PROPYLENE GLYCOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM CITRATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="368GB5141J" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM LAURYL SULFATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <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="mg" value="65"/>
                              <denominator unit="mL" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="31PZ2VAU81" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CARBAMIDE 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="15" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43170" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, DISPENSING"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="46122-557-05" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                                 </containerPackagedProduct>
                                 <subjectOf>
                                    <marketingAct>
                                       <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                       <statusCode code="active"/>
                                       <effectiveTime>
                                          <low value="20190101"/>
                                       </effectiveTime>
                                    </marketingAct>
                                 </subjectOf>
                              </asContent>
                           </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>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="M014" 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="20190101"/>
                           </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="L97e6c6ca-8177-4e26-89d7-3cce4d16228d">
               <id root="2f39c762-bcb9-c030-e063-6294a90a4558"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>
                  <content styleCode="italics">Drug Facts</content>
               </title>
               <text>
                  <paragraph/>
               </text>
               <effectiveTime value="20250220"/>
            </section>
         </component>
         <component>
            <section ID="L58f97246-bad1-4c91-a879-c0f12dfb6cc2">
               <id root="2f39c762-bcba-c030-e063-6294a90a4558"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="italics">Active ingredient</content>
               </title>
               <text>
                  <paragraph>Carbamide peroxide 6.5%</paragraph>
               </text>
               <effectiveTime value="20190328"/>
               <component>
                  <section ID="L3b3a1111-8403-4f86-8fb3-cd843a50e03a">
                     <id root="2f39c762-bcbb-c030-e063-6294a90a4558"/>
                     <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
                     <title>
                        <content styleCode="italics">Purpose</content>
                     </title>
                     <text>
                        <paragraph>Earwax removal aid</paragraph>
                     </text>
                     <effectiveTime value="20190328"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="L15630fb9-ffb4-4d67-9e3d-383a7e597027">
               <id root="2f39c762-bcbc-c030-e063-6294a90a4558"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="italics">Uses</content>
               </title>
               <text>
                  <paragraph>for occasional use as an aid to soften, loosen, and remove excessive earwax</paragraph>
               </text>
               <effectiveTime value="20190328"/>
            </section>
         </component>
         <component>
            <section ID="Lcfa924a0-7b1e-403d-93de-ad84d59c3cbd">
               <id root="2f39c762-bcbd-c030-e063-6294a90a4558"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="italics">Warnings</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">﻿For use in the ear only</content>
                  </paragraph>
               </text>
               <effectiveTime value="20250220"/>
               <component>
                  <section ID="L840691b3-0683-408e-8cc4-5b157aaf3567">
                     <id root="2f39c762-bcbe-c030-e063-6294a90a4558"/>
                     <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
                     <title>Ask a doctor beofre use if you have</title>
                     <text>
                        <list listType="unordered">
                           <item>ear drainage or discharge</item>
                           <item>ear pain</item>
                           <item>irritation, or rash in the ear</item>
                           <item>dizziness</item>
                           <item>an injury or perforation (hole) of the ear drum</item>
                           <item>recently had ear surgery</item>
                        </list>
                     </text>
                     <effectiveTime value="20250220"/>
                  </section>
               </component>
               <component>
                  <section ID="L5646de80-595a-44c1-9fc7-79542199a658">
                     <id root="2f39c762-bcbf-c030-e063-6294a90a4558"/>
                     <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
                     <title>When using this product</title>
                     <text>
                        <paragraph>avoid contact with the eyes</paragraph>
                     </text>
                     <effectiveTime value="20190328"/>
                  </section>
               </component>
               <component>
                  <section ID="L8f795fde-c751-403f-b412-77cc66fbe7e5">
                     <id root="2f39c762-bcc0-c030-e063-6294a90a4558"/>
                     <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>you need to use for more than 4 days</item>
                           <item>excessive ear wax remains after use of this product</item>
                        </list>
                     </text>
                     <effectiveTime value="20250220"/>
                  </section>
               </component>
               <component>
                  <section ID="Lf71c1814-e649-4fee-b886-b7594fe857c5">
                     <id root="2f39c762-bcc1-c030-e063-6294a90a4558"/>
                     <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 (1-800-222-1222) right away.</paragraph>
                     </text>
                     <effectiveTime value="20250220"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="L52ff9eba-9fa4-42b9-b1b3-d9dc4675a5b0">
               <id root="2f39c762-bcc2-c030-e063-6294a90a4558"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="italics">Directions</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">FOR USE IN THE EAR ONLY</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">﻿Adults and children over 12 years of age:</content>
                  </paragraph>
                  <list listType="unordered">
                     <item>Tilt head sideways and place 5 to 10 drops into ear</item>
                     <item>Tip of applicator should not enter ear canal</item>
                     <item>Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear</item>
                     <item>Use twice daily for up to 4 days if needed, or as directed by a doctor</item>
                     <item>Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe</item>
                     <item>
                        <content styleCode="bold">Children under 12 years: </content>consult a doctor
 
  </item>
                  </list>
               </text>
               <effectiveTime value="20250220"/>
            </section>
         </component>
         <component>
            <section ID="L3fc058e4-40af-4617-af86-6d58e0172329">
               <id root="2f39c762-bcc3-c030-e063-6294a90a4558"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>
                  <content styleCode="italics">Other information</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>Avoid exposing bottle to excessive heat and direct sunlight </item>
                     <item>Store bottle in the outer carton </item>
                     <item>Do not store above 25°C (77°F)</item>
                     <item>Keep cap on bottle when not in use</item>
                     <item>Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.</item>
                     <item>Do not use if tamper-evident safety seal is broken or missing</item>
                  </list>
               </text>
               <effectiveTime value="20250220"/>
            </section>
         </component>
         <component>
            <section ID="L93f97bd0-bba9-40ba-9190-b7ee209d92a2">
               <id root="2f39c762-bcc4-c030-e063-6294a90a4558"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="italics">Inactive ingredients</content>
               </title>
               <text>
                  <paragraph>anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water</paragraph>
               </text>
               <effectiveTime value="20250220"/>
            </section>
         </component>
         <component>
            <section ID="L7ed0252d-fbb7-433c-8fc5-a1a2379dbb18">
               <id root="2f39c762-bcc5-c030-e063-6294a90a4558"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>
                  <content styleCode="italics">Questions?</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">1-800-328-5890</content>
                  </paragraph>
                  <paragraph>Weekdays 8:30-5:00 CST</paragraph>
               </text>
               <effectiveTime value="20250220"/>
            </section>
         </component>
         <component>
            <section ID="L7cea0939-c3fe-4cbb-ac63-bd20892857a8">
               <id root="2f39c762-bcc6-c030-e063-6294a90a4558"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Package Labeling:</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="Ld64b5735-3ed8-441e-a044-e2c6115e31f1"/>
                  </paragraph>
               </text>
               <effectiveTime value="20250220"/>
               <component>
                  <observationMedia ID="Ld64b5735-3ed8-441e-a044-e2c6115e31f1">
                     <text>Label4</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Label4.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>