Label: DERMOPLAST PAIN RELIEVING- benzocaine and levomenthol spray

  • NDC Code(s): 16864-680-01, 16864-680-02, 16864-680-03
  • 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 ingredientsPurpose
    Benzocaine 20%Topical analgesic
    Menthol 0.5%Topical analgesic
  • Uses

    for temporary relief of pain and itching associated with

    • sunburn
    • insect bites
    • minor cuts
    • scrapes
    • minor burns
    • minor skin irritations
  • 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.

    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.

    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

    Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 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

    acetylated lanolin alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85

  • 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®
    Pain Relieving Spray

    HOSPITAL STRENGTH

    PAIN, BURN
    & ITCH

    RELIEVES PAIN FROM:
    Minor Cuts & Scrapes, Burns,
    Sunburns and Bug Bites

    Fast Itch & Burn Relief

    Provides Fast
    Pain Relief

    Cools and
    Comforts

    Soothing Aloe
    & Lanolin

    NET WT. 2.75 oz (78 g)

    PRINCIPAL DISPLAY PANEL - 78 g Can Label
  • INGREDIENTS AND APPEARANCE
    DERMOPLAST PAIN RELIEVING 
    benzocaine and levomenthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-680
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    BUTANE (UNII: 6LV4FOR43R)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-680-0178 g in 1 CAN; Type 0: Not a Combination Product01/01/2014
    2NDC:16864-680-0256 g in 1 CAN; Type 0: Not a Combination Product01/01/201412/31/2023
    3NDC:16864-680-0385 g in 1 CAN; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2014
    Labeler - Advantice Health, LLC (192527062)
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