Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 28, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Flammable. For external use only. Keep away from heat or flame.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • 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

    • Store between 59-86℉ (15-30℃)
    • Avoid freezing and excessive heat above 104℉ (40℃)
  • Inactive ingredients

    Water, Propylene Glycol, Glycerol, Carbomer, Aminomethyl Propanol

  • Package Label - Principal Display Panel

    55

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74737-2011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL38.5 mL  in 55 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.275 mL  in 55 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.165 mL  in 55 mL
    WATER (UNII: 059QF0KO0R) 15.675 mL  in 55 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.275 mL  in 55 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.11 mL  in 55 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74737-2011-8240 in 1 CARTON04/10/2020
    1NDC:74737-2011-155 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:74737-2011-048 in 1 CARTON05/20/2020
    2NDC:74737-2011-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:74737-2011-648 in 1 CARTON05/20/2020
    3NDC:74737-2011-4300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:74737-2011-74 in 1 CARTON05/20/2020
    4NDC:74737-2011-53785 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2020
    Labeler - Zhejiang Yuantiao Cosmetics Co., Ltd. (413798466)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Yuantiao Cosmetics Co., Ltd.413798466manufacture(74737-2011) , label(74737-2011)
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