Label: MOISTURIZING HAND SANITIZER WITH ALOE 62 PERCENT- ethyl alcohol gel

  • 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 January 16, 2022

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTISEPTIC

  • USES

    • decreases bacteria on the skin that could cause disease
    • recommended for repeated use

  • WARNINGS

    For external use only: hands

    Flammable. Keep away from fire or flame.

    When using this product

    • Keep out of eyes. In case of contact with eyes flush thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
  • 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.
    • FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.
    • NOT RECOMMENDED FOR INFANTS.

  • OTHER INFORMATION

    • DO NOT STORE ABOVE 105°F
    • MAY DISCOLOR SOME FABRICS
    • HARMFUL TO WOOD FINISHES AND PLASTICS
  • INACTIVE INGREDIENTS

    Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Triethanolamine, Fragrance (Parfum), Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Denatonium Benzoate, Phenoxyethanol, Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090)

  • PRINCIPAL DISPLAY PANEL

    01b LBL_ST_Keep Clean w-Aloe_12oz

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING HAND SANITIZER WITH ALOE   62 PERCENT
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76891-117
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76891-117-1189 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    2NDC:76891-117-12360 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    3NDC:76891-117-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    4NDC:76891-117-14355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - SCENT THEORY PRODUCTS LLC (101216246)
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