<?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="a8c66cd6-57f9-179f-e053-2995a90a0be5"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>The villiages Hand Sanitizer</title>
   <effectiveTime value="20200623"/>
   <setId root="be1e26a7-2958-44d8-b38a-250f41200d92"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="421299845"/>
            <name>iHotel Guest Amenities Co.,Ltd</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id root="1.3.6.1.4.1.519.1" extension="421299845"/>
                        <name>iHotel Guest Amenities Co.,Ltd</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" displayName="manufacture" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <product>
                              <manufacturedProduct classCode="MANU">
                                 <manufacturedMaterialKind>
                                    <code code="71004-103" codeSystem="2.16.840.1.113883.6.69"/>
                                 </manufacturedMaterialKind>
                              </manufacturedProduct>
                           </product>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="a8c66dbd-5886-2c67-e053-2a95a90a1067"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20200623"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="71004-103" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>The Villages Hand Sanitizer With Aloe and Vitamin E Extract</name>
                        <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SOLUTION"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Alcohol</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="Z135WT9208" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CARBOMER 934</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="9O3K93S3TK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TROLAMINE</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="9E8X80D2L0" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>.ALPHA.-TOCOPHEROL ACETATE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="ZY81Z83H0X" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ALOE VERA LEAF</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mL" value="62"/>
                              <denominator unit="mL" value="100"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ALCOHOL</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ALCOHOL</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="60" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="71004-103-01" 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="20200620"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="500" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="71004-103-02" 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="20200620"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="part333A" root="2.16.840.1.113883.3.149"/>
                           <code code="C73604" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC monograph not final"/>
                           <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="20200620"/>
                           </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 root="a8c66cd6-57fa-179f-e053-2995a90a0be5"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <text>
                  <paragraph>Ethyl Alcohol 62% </paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-57fb-179f-e053-2995a90a0be5"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>Antimicrobial</paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-57fc-179f-e053-2995a90a0be5"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Use</title>
               <text>
                  <paragraph>Hand sanitizer to help reduce bacteria on the skin</paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-57fd-179f-e053-2995a90a0be5"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings</title>
               <text>
                  <paragraph>For external use only.</paragraph>
                  <paragraph>Non Medical. Flammable. Keep away from fire or flame</paragraph>
                  <paragraph>Do not use in or near eyes, In case of contact, rinse thoroughly with water</paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-57fe-179f-e053-2995a90a0be5"/>
               <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
               <text>
                  <paragraph>Stop use and consult a doctor if irritation or rash occurs</paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-57ff-179f-e053-2995a90a0be5"/>
               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <text>
                  <paragraph>Keep out of reach of children. If swallowed, seek immediate medical help or contact a poison control center</paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-5800-179f-e053-2995a90a0be5"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <list listType="unordered">
                     <item>Apply literally to the hands and rub until dry</item>
                  </list>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a8c66cd6-5801-179f-e053-2995a90a0be5"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredients</title>
               <text>
                  <paragraph>Water, Carbomer, Triethanolamine, Glycerin, Alor Barbardensis Leaf Juice, Tocopheryl Acetate</paragraph>
               </text>
               <effectiveTime value="20200620"/>
            </section>
         </component>
         <component>
            <section ID="Le62d60c9-9ee5-4127-9a5f-a575cae93864">
               <id root="a8c66cd6-5802-179f-e053-2995a90a0be5"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L2d3d07be-f1d9-4b79-993a-25c5fddaa7de"/>
                  </paragraph>
               </text>
               <effectiveTime value="20200623"/>
               <component>
                  <observationMedia ID="L2d3d07be-f1d9-4b79-993a-25c5fddaa7de">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="the villages01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>