Label: CANDY APPLE- 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 June 4, 2014

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    carbomer 940, PEG-12

    dimethicone, tocopheryl

    acetate, triethanomaline,

    blue 1, water

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol, 65 % v/v

  • PURPOSE

    Purpose  Antimicrobial

  • INDICATIONS & USAGE

    Uses

    hand sanitizer to help

    reduce bacteria on skin

  • DO NOT USE

    Do not use in or near the eyes.

    In case of contact, rinse eyes

    thoroughly with water.

  • STOP USE

    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)

  • WARNINGS

    Warning

    For external use only


    Flammable, keep away from fire or flame.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    CANDY APPLE  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-012
    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
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLE (candy apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-012-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2014
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-012)
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