Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 15828-196-01
  • Packager: Zermat Internacional S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • Drug Facts

  • Active ingredient[s]

    Alcohol 80% v/v

    Purpose

    Antiseptic

  • Use[s]

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

  • Warnings

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

    Do not use

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

    When using this product

    keep out eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    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.

    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 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients:

    Purified water, Carbomer, Fragrance, AMP, Blue No. 1 CI. 42090

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15828-196
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ADENOSINE PHOSPHATE (UNII: 415SHH325A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15828-196-01195 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/24/2020
    Labeler - Zermat Internacional S.A. de C.V. (812820712)
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