Label: DERMOPLAST KIDS FIRST AID- benzethonium chloride and benzocaine spray

  • NDC Code(s): 16864-660-01
  • Packager: Advantice Health, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients(To Deliver) Purpose
    Benzethonium chloride 0.2%First aid antiseptic
    Benzocaine 15%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

    Flammabledo 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

    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 barbadensis leaf juice, dimethyl ether, methylal, PEG-8

  • 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 - 57 g Can Label

    Dermoplast ®
    KIDS

    Antiseptic & Pain
    Relieving Spray

    FIRST AID
    ANTIBACTERIAL & PAIN
    RELIEVING SPRAY

    STING FREE FORMULA

    KILLS 99% OF GERMS
    To Help Prevent Infection †

    For Minor Cuts, Scrapes & Burns

    Disinfects Minor
    Burns & Wounds

    #1
    Doctor
    Recommended
    Brand*

    Provides Fast
    Pain Relief

    NET WT. 2 oz (57 g)

    PRINCIPAL DISPLAY PANEL - 57 g Can Label
  • INGREDIENTS AND APPEARANCE
    DERMOPLAST KIDS  FIRST AID
    benzethonium chloride and benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-660
    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) BENZOCAINE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    METHYLAL (UNII: 7H1M4G2NUE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL ETHER (UNII: AM13FS69BX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-660-0157 g in 1 CAN; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/01/2022
    Labeler - Advantice Health, LLC. (192527062)
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