Label: 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 8, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antiseptic hand rub.

  • Use

    Kills 99.9% of most common germs.
    Use in the absence of water or towels.

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not mix with detergent or other chemicals.

  • Do not use

    Avoid contact with eyes or wound, if product gets into eyes, rinse thoroughly with water.

  • WHEN USING

    When using this product, do not use in or near the eyes or wound.

    Use in well ventilated environment.

  • STOP USE

    Stop using this product if skin irritation occurs and consult a doctor immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, seek medical help immediately.

  • Directions

    • Dispense product evenly on palms or on material surface and rub your hands until dry.
    • Children should be under adult supervision when using this product.
    • No dilute required.
  • Other information

    • Store at room temperature.
    • Product may cause discoloration on certain fabrics or materials.
  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Aloe extract, Essence.

  • Package Label - Principal Display Panel

    050-1050-2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76846-1011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76846-1011-150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/08/2020
    Labeler - Xiamen Luwei Industrial Co., Ltd (416782594)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Luwei Industrial Co., Ltd416782594manufacture(76846-1011) , label(76846-1011)
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