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 11, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help decrease bacteria on the skin.
    • when water, soap & towel are not available.
    • recommended for repeated use
  • Warnings

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

    Do not apply around eyes.

    Do not use

    In ears & mouth

    When using this product

    avoid contact with eyes, In case of contact flush eyes with water.

    Stop use and ask a doctor

    If redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • pump as needed into your palms and thoroughly spread on both hands.
    • rub into skin until dry.
  • Other information

    • store at 20°C (68° to 77°F).
    • may discolor fabrics.
  • Inactive ingredients:

    Purified water, Carbomer, Triethanolamine, Glycerin, Tocopheryl acetate.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73260-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73260-010-0059.14 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:73260-010-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - Yuyao YiJia Daily Chemical Co., Ltd. (529646545)
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