Label: SKIN SHIELD- benzethonium chloride and dyclonine hydrochloride 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 June 22, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Benzethonium chloride 0.2%First aid antiseptic
    Dyclonine hydrochloride 0.75%Topical analgesic
  • Uses

    first aid for the temporary relief of pain and to help protect against infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Do not use for longer than 1 week unless directed by a doctor.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if the condition gets worse, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

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

  • Directions

    Adults and children 2 years of age and older:

    • Clean the affected area.
    • Dry thoroughly.
    • Brush a small amount of product on the area 1 to 3 times daily and let dry.
    • Hold knees, elbows, knuckles in bent position during application and drying.
    • For more protection, apply second coat.

    Children under 2 years of age:

    • Consult a doctor.
  • Other information

    • To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently while still wet.
    • Cap bottle tightly
    • Store at room temperature 15°-25°C (59°-77°F).
    • Keep carton for full drug facts.
  • Inactive ingredients

    acetone, amyl acetate, castor oil, drometrizole, ethyl acetate, nitrocellulose, SD alcohol 40-B

  • Questions?

    call 1-800-344-7239

  • SPL UNCLASSIFIED SECTION

    Distributed by: Insight Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton

    ECONOMY SIZE

    Skin Shield®
    Liquid Bandage
    First Aid Antiseptic
    Pain Reliever

    NET WT. 0.9 fl oz (26.6 ml)

    PRINCIPAL DISPLAY PANEL - 26.6 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SKIN SHIELD 
    benzethonium chloride and dyclonine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-293
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride0.0532 mL  in 27 mL
    Dyclonine Hydrochloride (UNII: ZEC193879Q) (Dyclonine - UNII:078A24Q30O) Dyclonine Hydrochloride0.0997 mL  in 27 mL
    Inactive Ingredients
    Ingredient NameStrength
    Acetone (UNII: 1364PS73AF)  
    Amyl Acetate (UNII: 92Q24NH7AS)  
    Castor Oil (UNII: D5340Y2I9G)  
    Drometrizole (UNII: 5X93W9OFZL)  
    Ethyl Acetate (UNII: 76845O8NMZ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-293-2424 in 1 CASE
    11 in 1 BOX
    126.9 mL in 1 BOTTLE
    2NDC:63736-293-3636 in 1 CASE
    21 in 1 BOX
    229.6 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2010
    Labeler - Insight Pharmaceuticals (176792315)
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