Label: BLUEBERRY 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 July 7, 2021

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  • Drug facts

  • ACTIVE INGREDIENT

    Active ingredient .............purpose

    alcohol Denate: 70%(v/v)..... Antibacterial

  • Use

    To decrease bacteria on the skin that could cause disease.

  • Warnings

    For external use only-hands

    keep out of eyes- avoid contact with broken skin.

    Keep away from fire.

    Stop use and ask a dosctor if irritation or radness develops

    Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

  • Direction

    Rub a dime sized drop into hands.

    For children under 8 use under adult supervision

  • Inactive ingredients

    INACTIVE INGREDIENTS: WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ c10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
    MAY CONTAIN: FD&C RED 40, D&C RED 33, FD&C BLUE 1, FD&C YELLOW 5.

  • Questions?

    1-212-779-0544 weekdays

  • PRINCIPAL DISPLAY PANEL

    77901-009-01

  • INGREDIENTS AND APPEARANCE
    BLUEBERRY SCENTED HAND SANITIZER  01
    alochol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77901-009
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0003 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.16 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 36.2397 g  in 100 mL
    BLUEBERRY (UNII: 253RUG1X1A) 0.2 g  in 100 mL
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.2 mL  in 100 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.2 mL  in 100 mL
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77901-009-0159 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(77901-009)
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