Label: DERMA-GLOVE- ethanol, triclosan spray

  • 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) hand sanitizer spray
  • ACTIVE INGREDIENT

    Active Ingredient

    Ethanol 60%..................................................................Antibacterial

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

  • PURPOSE

    Antiseptic/Antimicrobial hand sanitizer spray

  • INDICATIONS & USAGE

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease
    • Recommended for repeated use
  • WARNINGS AND PRECAUTIONS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    When using this product do not use in or near eyes. In case of eye contact, rinse eyes thoroughly 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. If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:
    • Spray enough product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Rinse with water after use
    • Children under 6 years of age should be supervised when using this product
  • GENERAL PRECAUTIONS

    • Do not store above 110o F (43o C)
    • For additional information, see Material Safety Data Sheet (MSDS).
  • INACTIVE INGREDIENT

    Deionized Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Polyoxyethylene (20) Sorbitan Monooleate, 2-Amino-2-methyl-1-propanol, Polyquaternium-69, Citric Acid and Sodium Citrate

    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  
    ethanol, triclosan spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24673-249
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ethanol (UNII: 3K9958V90M) (Ethanol - UNII:3K9958V90M) Ethanol0.58 g  in 1.00 g
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.003 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24673-249-0113.65 g in 1 BOTTLE, SPRAY
    2NDC:24673-249-023494.4 g in 1 BOTTLE, SPRAY
    3NDC:24673-249-0317472 g in 1 DRUM
    4NDC:24673-249-04192192 g in 1 DRUM
    5NDC:24673-249-05873600 g in 1 DRUM
    6NDC:24673-249-061223040 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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