Label: 3 PACK 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 July 6, 2020

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  • Active ingredient

    Alcohol 75%

  • Purpose

    Antiseptic

  • Use

    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

    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

    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 Posion Control Center right away.

  • Directions

    Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

  • Other information

    Store below 106 F (41C).

  • Inactive ingredients

    water,

    glycereth-26,

    aloe barbadensis extract

    carbomer,

    sodium hydroxide,

    may contain: red 33, red 4, yellow 5, blue 1, red 40

  • Label

    labellabel 2label 3label 4label 5

  • INGREDIENTS AND APPEARANCE
    3 PACK HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    ALOE (UNII: V5VD430YW9)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74657-003-0129.6 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - Double Body Biotech Limited (560246954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Double Body Biotech Limited560246954manufacture(74657-003)
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