Label: ANTIBACTERIAL HAND SANITIZER gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 13, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% v/v. Purpose: Antibacterial

  • Purpose

    Antibacterial

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or fame

  • Do not use

    • In children less than 2 months of age
    • On open sian wounds
  • WHEN USING

    When using this product avoidontact with eyes. lf contact occurrinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor ifimitaton or rash develops andcontinues for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If swallowed, get modical help orcontact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Do not store above 105"F
    • May or some rand
    • Harmfu to wood finishes and plastics
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, CarbomerFragrance, Gycein, Prolene Glycol, Tocopherol Acetate,Triethanolamine, Water

  • Package Label - Principal Display Panel

    12345

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76716-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76716-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    2NDC:76716-006-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    3NDC:76716-006-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    4NDC:76716-006-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    5NDC:76716-006-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/13/2020
    Labeler - Zhejiang Innoadir Industry and Trade Co.,Ltd (411892772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Innoadir Industry and Trade Co.,Ltd411892772manufacture(76716-006)
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