Label: BIRTHDAY CAKE ANTI-BACTERIAL SCENTED HAND SANITIZER- alcohol gel

  • NDC Code(s): 56136-163-01
  • 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 January 21, 2022

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  • Drug Facts

  • Active ingredient

    Alcohol 65%

    Purpose

    Antiseptic

    USE

    Decrease bacteria on hands

  • Warnings

    For external only.

    Flammable-keep product awau from fire or flame.

    Waring - Choking Hazard

    Small parts. Not for children under 3 years.

    When using this product

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

    Stop use and ask a doctor if

    • irritation and redness develops and persists.

    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.

  • Inactive ingredients

    Alcool Denat., Water (Aqua), Acrylates/c 10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrace (Parfum). May contain: FD&C No. 4 (C.l. 14700), D&C Red No. 33 (Cl 17200), FD&C Yellow 5, FD&C Blue No. 1 (Cl 42090).

  • package

    label image

  • INGREDIENTS AND APPEARANCE
    BIRTHDAY CAKE ANTI-BACTERIAL SCENTED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-163-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/21/2022
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-163)
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