Label: HAND SANITIZER WITH VITAMIN E- alcohol liquid

  • 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 September 11, 2020

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  • Active ingredient

    Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin, only when water is not available

  • Warnings

    For external use only. Flammable, keep away from fire and flames

  • When using this product

    ■ do not get into eyes. ■ if contact occurs, rinse eyes thoroughly with water

  • Stop use and ask a doctor if

    ■ irritation and redness develop

  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ wet hands thoroughly with product and allow to dry without wiping

  • Inactive ingredients

    Water, PEG-40 Hydrogenated Castor Oil, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Denatonium Benzoate, Tocopheryl Acetate

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  WITH VITAMIN E
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74177-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74177-027-30887 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
    2NDC:74177-027-341000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
    3NDC:74177-027-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
    4NDC:74177-027-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2020
    5NDC:74177-027-283789 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/03/2020
    6NDC:74177-027-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/14/2020
    7NDC:74177-027-0389 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/2020
    8NDC:74177-027-5050 in 1 BOX09/07/2020
    8NDC:74177-027-072 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/29/2020
    Labeler - K7 Design Group Inc. (080357784)
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