Label: PUMPKIN JUICE SCENTED HAND SANITIZER 01- alochol gel

  • 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 May 26, 2021

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  • Active ingredient Purpose

    Alcohol Denat. 70%(v/v)..... Antibacterial

  • Use

    To decrease bacteria on the skin that could cause disease.

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    When using this product

    • Keep out of eyes.
    • Avoid contact with broken skin.

    Stop use and ask a doctor if

    • Irritation or redness develops.

    Keep out of reach of children

    • Do not inhale or ingest
    • if swallowed, get medical help or contact a poison control center right away.
  • Direction

    Rub a dime sized drop into hands.

    For children under 8 use under adult supervision

  • Inactive ingredients

    WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
    MAY CONTAIN: FD&C YELLOW NO. 5( CI19140), FD&C RED NO. 40( CI16035), FD&C BLUE NO.1(CI 42090), D&C RED NO. 33( CI 17200).

  • Questions?

    1-212-779-0544 weekdays

  • PRINCIPAL DISPLAY PANEL

    77901-046-01

  • INGREDIENTS AND APPEARANCE
    PUMPKIN JUICE SCENTED HAND SANITIZER  01
    alochol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77901-046
    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
    TROLAMINE (UNII: 9O3K93S3TK) 0.16 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 36.2397 g  in 100 mL
    GLYCOSMIS CITRIFOLIA WHOLE (UNII: K1Z43JI31W) 0.2 g  in 100 mL
    PUMPKIN (UNII: SYW0QUB89Y) 0.2 mL  in 100 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.2 mL  in 100 mL
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0001 g  in 100 mL
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0001 g  in 100 mL
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77901-046-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/19/2020
    Labeler - Foshan Astar Industry Co., Ltd (421358695)
    Registrant - Foshan Astar Industry Co., Ltd (421358695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Astar Industry Co., Ltd421358695manufacture(77901-046)
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