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

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 24, 2021

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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

    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.

    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 Product01/01/2014
    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 NOT FINALpart34801/01/2014
    Labeler - Advantice Health, LLC (192527062)
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