Label: CANDY APPLE SCENTED ANTI-BACTERIAL HAND GEL- ethyl alcohol 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 December 13, 2017

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol, 65% v/v

  • PURPOSE

    Purpose  Antimicrobial

  • INDICATIONS & USAGE

    Uses  hand sanitizer to help

    reduce bacteria on skin

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away

    from fire or flame.

    Do not use in or near the eyes

    In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation, excessive redness

    or rash develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of

    children. If swallowed, get

    medical help or contact a Poison

    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions  Put a dime sized

    drop onto hands and rub

    together briskly until dry.

  • STORAGE AND HANDLING

    Other information

    Store below 110° F (43° C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, glycerin, propylene

    glycol, fragrance, carbomer,

    triethanolamine, blue 1, yellow 5

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CANDY APPLE SCENTED  ANTI-BACTERIAL HAND GEL
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE (candy apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43473-820-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/12/2017
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
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