Label: HAND SANITIZER GEL- alcohol solution

  • 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 May 19, 2020

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  • DESCRIPTION

    Hand Sanitizer Gel

    Moisturizing with Aloe

    Effective at eliminating more than 99.9% of many common harmful germs & bacteria in as little as 15 seconds.

  • Active Ingredient(s)

    Ethyl alcohol 70% v/v Purpose Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

  • Do not use

    • in 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 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.

  • 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 in your palm to thoroughly cover your hands Rub hands together briskly until dry

    No rinsing required

    No towels needed

  • Other information

    Do not store above 110°F (43°C) May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water (Aqua), Aloe Vera, Propylene Glycol, Carboxethyl Acrylate Crosspolymer, Fragrance, FD&C Blue #1, FD&C Yellow #5

  • Package Label - Principal Display Panel

    24OZ709.76 mL NDC: 78046-1124-1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78046-1124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HEPTANAL (UNII: 92N104S3HF)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78046-1124-1709.76 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/19/2020
    Labeler - Hill & Markes, Inc. (013616594)
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