Label: DERMOPLAST FIRST AID- benzethonium chloride and benzocaine 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 March 12, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Benzethonium chloride 0.2%First aid antiseptic
    Benzocaine 20%Topical analgesic
  • Uses

    first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    Flammable do not use near heat, flame, or fire or while smoking

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    Do not use

    • in the eyes
    • over large areas of the body

    When using this product

    • avoid contact with eyes. Do not spray in the face or mouth.
    • use only as directed
    • intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • itching, rash or irritation develops

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

  • Directions

    • clean the affected area
    Adults and children 2 years of age and olderapply a small amount to affected area 1 to 3 times daily
    Children under 2 years of ageconsult a doctor
    • to use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray.
    • to apply to face, spray in palm of hand and gently apply
  • Other information

    • avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration
    • store at 20-25°C (68-77° F)
  • Inactive ingredients

    aloe vera gel (decolorized), cyclomethicone, dipropylene glycol, isobutane, SD alcohol 40-B (73% v/v), tocopheryl acetate (vitamin E acetate)

  • Questions?

    1-800-345-0032
    Mon - Fri 8AM- 5PM EST
    Dermoplast.com

  • SPL UNCLASSIFIED SECTION

    Distributed by Advantice Health, LLC
    Cedar Knolls, NJ 07927

  • PRINCIPAL DISPLAY PANEL - 78 g Can Label

    Dermoplast®
    Antiseptic & Pain
    Relieving Spray

    HOSPITAL STRENGTH

    FIRST AID
    ANTIBACTERIAL SPRAY

    KILLS 99% OF GERMS
    To Prevent Infection

    For Minor Cuts, Scrapes & Burns

    Disinfects
    Burns &
    Wounds

    Provides
    Fast
    Pain Relief

    Soothing
    Aloe &
    Vitamin E

    NET WT. 2.75 oz (78 g)

    PRINCIPAL DISPLAY PANEL - 78 g Can Label
  • INGREDIENTS AND APPEARANCE
    DERMOPLAST FIRST AID 
    benzethonium chloride and benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOBUTANE (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-670-0178 g in 1 CAN; Type 0: Not a Combination Product01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A01/01/2010
    Labeler - Advantice Health, LLC (192527062)
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