Label: ENCHANTED FOREST HAND SANITIZER BODYCOLOGY- ethyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 25, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient    Purpose
    Ethyl Alcohol 75%    Antiseptic

    Uses: To decrease bacteria on the skin.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours.


    Warnings
    For external use only.

    FLAMMABLE. Keep away from heat and flame.

    When using this product
    -Avoid contact with eyes. If contact occurs, flush eyes with water.
    -Avoid contact with broken skin.


    Directions
    -Wet hands with product.
    -Briskly rub hands together until dry.
    -For children under 6, use only under adult supervision.
    -Not recommended for infants.

    Inactive ingredients Water (Aqua, Eau), Fragrance (parfum), propylene glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007)
    May Contain: FD and C No.4 (CI 14700), FD and C Yellow No. 5 (CI 19140) FD and C Blue No. 1 (CI 42090), D and C Red No. 33 (CI 17200)

  • PRINCIPAL DISPLAY PANEL

    Bodycology
    MOISTURIZING HAND SANITIZER
    with Aloe Vera
    kills 99% of germs without water
    Enchanted Forest

    30mL    1 FL OZ




    image of backer



    image of bottle

  • INGREDIENTS AND APPEARANCE
    ENCHANTED FOREST HAND SANITIZER  BODYCOLOGY
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GELATIN (UNII: 2G86QN327L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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:51345-051-011 in 1 BLISTER PACK
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E04/07/2011
    Labeler - Advanced Beauty Systems, Inc. (129986613)
    Registrant - Advanced Beauty Systems, Inc. (129986613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51345-051)