Label: INSTANT HAND SANITIZER- alcohol 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 April 29, 2020

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  • Active Ingredient(s)

    Ethyl alcohol 75% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable.

    Keep away from heat or flame.

    For external use only.

  • Do not use

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

    In case of contact, rinse eyes thoroughly with water.

  • WHEN USING

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

    In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears or lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 86℉ (30℃).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Glycerin, Carbomer, Fragrance.

  • Package Label - Principal Display Panel

    73557-23073557-23573557-237

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL262.5 mL  in 350 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73557-237-01350 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    INSTANT HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL168.75 mL  in 225 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73557-235-01225 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    INSTANT HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-230
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CLOVE (UNII: K48IKT5321)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73557-230-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    Labeler - Shanghai Chuangshi Industry Group Co., Ltd (546872672)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Industry Group Co., Ltd546872672manufacture(73557-230, 73557-235, 73557-237) , label(73557-230, 73557-235) , relabel(73557-237)
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