Label: DERMA-GLOVE- triclosan soap

  • 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 1, 2010

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  • DESCRIPTION


    DERMA-GLOVE(R) rinse-off liquid handsoap
  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan 0.3%.............................................Antiseptic

  • PURPOSE

    Antiseptic hand soap

  • INDICATIONS & USAGE

    • Helps eliminate germs on the hands
  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only.

    When using this product do not use in or near eyes. In case of eye contact, flush with water.

    Stop use and ask a doctor if skin irritation or redness develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the Reach of Children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:
    • Wash hands and rinse
    • Children under 6 years of age should be supervised when using this product
  • GENERAL PRECAUTIONS

    For additional information, see Material Safety Data Sheet (MSDS).
  • INACTIVE INGREDIENT

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Hydrolyzed Jojoba Esters, Propylene Glycol, Cocamidopropyl Betaine, Ethanol, Cocamide DEA, Peg16 Macadamia Glycerides, Acrylate Crosspolymer, Polyquaternium-69, Phenoxyethanol, Citric Acid and Sodium Citrate, Disodium EDTA

    Questions or Comments?

    Call 1-888-300-1225 Monday through Friday 8:00 AM to 5:00 PM

  • PRINCIPAL DISPLAY PANEL

    LABEL FILELABEL

  • INGREDIENTS AND APPEARANCE
    DERMA-GLOVE 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24673-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan.03 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24673-247-0160.6 g in 1 BOTTLE, PUMP
    2NDC:24673-247-02121.2 g in 1 BOTTLE, PUMP
    3NDC:24673-247-03242.4 g in 1 BOTTLE, PUMP
    4NDC:24673-247-043878.4 g in 1 BOTTLE, PUMP
    5NDC:24673-247-0519392 g in 1 DRUM
    6NDC:24673-247-06213312 g in 1 DRUM
    7NDC:24673-247-07969600 g in 1 DRUM
    8NDC:24673-247-081357440 g in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33302/03/2010
    Labeler - RWM TECHNOLOGIES (003215779)
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