Label: BODY GLOVE FOR MEN ANTIBACTERIAL HAND SANITIZER TEA TREE AND VITAMIN E SCENTED- alcohol liquid

  • NDC Code(s): 56136-497-01
  • 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 November 13, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 70%

    Purpose

    Antibacterial

    Use

    Decreases bacteria on hands

  • Warnings

    For external use only.

    Flammbale, Keep product away from fire or flame.

    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

    Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Extract. May contain: FD&C Red No. 4 (C.I. 14700), FD&C Yellow No. 5 (C.I. 19140), D&C Red No. 33 (Cl 17200), FD&C Blue No. 1 (Cl 42090).

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    BODY GLOVE FOR MEN ANTIBACTERIAL HAND SANITIZER TEA TREE AND VITAMIN E SCENTED 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-497
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-497-01350 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/13/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-497)
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