Label: DERMACHANGE COLD THERAPY- menthol gel

  • NDC Code(s): 83520-131-08
  • Packager: Private Label Beauty and Wellness
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • ACTIVE INGREDIENT

    Menthol 2%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

  • WARNINGS

    For external use only.

    Do not use with other topical pain relievers, with heating pad or heating devices.

    When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly.

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. • Children under 12 years old, ask a doctor

  • INACTIVE INGREDIENT

    Ammonium hydroxide, blue 1, carbomer, copper PCA, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DERMACHANGE COLD THERAPY 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83520-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    COPPER PIDOLATE (UNII: 497G7G1SL1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    THYMOL (UNII: 3J50XA376E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83520-131-08227 g in 1 JAR; Type 0: Not a Combination Product10/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/27/2023
    Labeler - Private Label Beauty and Wellness (035014854)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(83520-131)
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