Label: INSTANT HAND SANITIZER- alcohol 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 October 2, 2020

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  • DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 77%v/v

    Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer helps reduce bacteria on the skin
    • Recommended for repeated use
  • Warnings

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

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor 

    if irritation or rash occurs and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Centre right away.

  • Directions

    • Place product in palm of hand 
    • Rub hands together until dry
    • Supervise children under 6 years of age when using product
  • Storage

    Store below 110°F (43°C)

  • Inactive ingredients

    Water (Aqua), Glycerin, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Propylene Glycol

  • Package Labeling: 100ml

    Bottle

  • Package Labeling: 500ml

    Bottle2

  • Package Labeling:5000ml

    Label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79699-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.77 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79699-000-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    2NDC:79699-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    3NDC:79699-000-195000 mL in 1 CAN; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Zidac Laboratories Ltd (222761253)
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