Label: BODYCOLOGY VANILLA CUPCAKE- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 April 8, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                             purpose

    Ethyl Alcohol 70%                          Antiseptic


    Uses: to decrease bacteria on the skin.

    Keep out of reach of children.

    Stop use and consult a 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.
    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. 


    Directions: Wet hands with product and allow to dry without wiping. 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 (Aloe Vera leaf juice), Ultramarines (CI77007)
    May contain: FD C Red No.4(CI 14700, Aka504), FD C Yellow No. 5 (CI 19140,Ki4), FD C Blue No.1 (CI 42090, Ao1), D C Red No 33(CI 17200,Aka227)


    Image of bottle label

  • PRINCIPAL DISPLAY PANEL

    Bodycology

    Moisturizing Hand Sanitizer

    30 mL 1 Fl Oz



    Image of blister label

  • INGREDIENTS AND APPEARANCE
    BODYCOLOGY  VANILLA CUPCAKE
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-992
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GELATIN (UNII: 2G86QN327L)  
    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:49035-992-021 in 1 BOTTLE
    1NDC:49035-992-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/09/2011
    Labeler - Wal-Mart Stores, Inc. (051957769)