Label: BODYCOLOGY WHITE GARDENIA ANTI-BACTERIAL SCRUBBING HAND SOAP- triclosan liquid

  • 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 May 3, 2010

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Triclosan

    Purpose  Antiseptic

    Uses  For handwashing to decrease bacteria on the skin.

    Warnings For external use only

    When using this product  Do not get into eyes.  If contact occurs, rinse eyes throughly with water.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions   Wet hands. Apply palmful to hands.  Scrub thoroughly for 30 seconds. Rinse.

    Inactive Ingredients  Water (Aqua, Eau), Sodium Laureth Sulfate, Glycerine, SD Alcohol 40B, Lauramide DEA, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Extract, Tetrasodium EDTA, Isopropyl Alcohol, Benzophenone-4, Polyethylene, Microcrystalline Wax, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Methylchloroisothiazolinone, Methylisothaizolinone. May Contain: Ultramarines (Cl 77007), Yellow 5 (Cl 19140), Yellow 6 (CL 15985), Yellow 10 (Cl 47005), Red 33 (Cl 17200), Red 4 (Cl 14700), Red 40 (Cl 16035), Blue 1 (Cl 42090), Green (Cl 42053), Ext. Violet (Cl 60730).

  • PRINCIPAL DISPLAY PANEL

    Front Label

  • DESCRIPTION

    back label

  • INGREDIENTS AND APPEARANCE
    BODYCOLOGY WHITE GARDENIA ANTI-BACTERIAL SCRUBBING HAND SOAP 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65663-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan.30 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65663-019-01236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/21/2009
    Labeler - American Blending and Filling (809226710)