Label: DERMOPLAST PAIN RELIEVING- benzocaine, menthol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Benzocaine 20%

    Menthol 0.5%

    Purpose

    Topical analgesic

  • Uses

    for temporary relief of pain and itching associated with • sunburn • insect bites • minor cuts • minor burns • minor skin irritations 

  • Warnings

    For external use only

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

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

    When using this product

    • avoid contact with eyes. Do not spray in the face of 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 older apply to affected area not more than 3 to 4 times daily
     Children under 2 years of age  consult 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 lanoline alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85

  • Questions?

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DERMOPLAST PAIN RELIEVING 
    benzocaine, menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-690
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTANE (UNII: 6LV4FOR43R)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-690-0178 g in 1 CAN; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/18/2022
    Labeler - Advantice Health (192527062)