<text/> <effectiveTime value="20200516"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="77706-001" codeSystem="2.16.840.1.113883.6.69"/> <name>Health People</name> <formCode code="C42934" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="GEL"/> <asEntityWithGeneric> <genericMedicine> <name>Alcohol</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator value="70" unit="mL"/> <denominator value="100" unit="mL"/> </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> <ingredient classCode="IACT"> <ingredientSubstance> <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/> <name>WATER</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="0A5MM307FC" codeSystem="2.16.840.1.113883.4.9"/> <name>CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE</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="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="9E8X80D2L0" codeSystem="2.16.840.1.113883.4.9"/> <name>ALPHA-TOCOPHEROL ACETATE</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator value="60" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="77706-001-01" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43173" displayName="BOTTLE, PLASTIC" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20200513"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C112160" displayName="Type 0: Not a Combination Product" codeSystem="2.16.840.1.113883.3.26.1.1" xsi:type="CE"/> </characteristic> </subjectOf> </asContent> <asContent> <quantity> <numerator value="236" unit="mL"/> <denominator value="1" unit="1"/> </quantity> <containerPackagedProduct> <code code="77706-001-02" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43173" displayName="BOTTLE, PLASTIC" codeSystem="2.16.840.1.113883.3.26.1.1"/> </containerPackagedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20200513"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C112160" displayName="Type 0: Not a Combination Product" codeSystem="2.16.840.1.113883.3.26.1.1" xsi:type="CE"/> </characteristic> </subjectOf> </asContent> </manufacturedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20200513"/> </effectiveTime> </marketingAct> </subjectOf> <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> <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="5c4e2f60-6e70-488d-a5d2-339fb92716bd"/> <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/> <title> <content styleCode="bold">Active Ingredient</content> Ethyl Alcohol 70%
<content styleCode="bold">Purpose</content> Antimicrobial
<content styleCode="bold">Uses</content> Hand sanitizer to help reduce bacteria on the skin.
<content styleCode="bold">Warnings</content> Flammable Keep away from Flames. When using this product Keep out of eyes. In case of contact with eyes, nose eyes Thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and contact a doctor if irritation develops or persists for more than 72 hours.
Keep out of reach of Children. If swallowed get immediate medical help or contact a poison control center right away.
<text/> <effectiveTime value="20200514"/> </section> </component> <component> <section> <id root="8e5e501e-fb09-419c-94fb-bb4351cc9867"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <title> <content styleCode="bold">Directions</content> Apply onto hands/skin, rub until dry.
<content styleCode="bold">Inactive ingredients</content> Water, Triethanolamine, Carbomer, Aloe Vera Gel, Glycerin, Propylene Glycol. Vitamin E
Package Label - Principal Display Panel Label 60 mL Label 236 mL 60 mL 236 mL