Label: AT HOME SIGNATURE COLLECTION HAND SANITIZER HARVEST APPLE- alcohol gel

  • NDC Code(s): 56136-044-01
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • 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 June 17, 2022

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  • Active ingredient

    Alcohol 70% w/w

    Purpose

    Antiseptic

  • Use

    Antiseptic cleanser; helps decrease bacteria on skin

  • Warnings

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

    When using this product

    avoid contact with the eyes; in case of contact, flush eyes with water.

    Stop use and ask a doctor if

    irritation or redness develops and persists.

    Keep out of reach of children.

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

  • Directions

    • Place enough product on your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate. May contain: Red 33 (CI 17200), Red 4 (CI 14700), Yellow 5 (CI 19140), Blue 1 (CI 42090).

  • Other information

     Store below 110°F (43°C). May discolor certain fabrics or surfaces.

  • Questions?

    call 1-800-548-4097

  • Label

    image of the label

  • INGREDIENTS AND APPEARANCE
    AT HOME SIGNATURE COLLECTION HAND SANITIZER  HARVEST APPLE
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-044-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/17/2022
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Registrant - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-044)
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