Label: MEDPRIDE COLD ICE ANALGESIC GEL- menthol gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 6, 2024

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  • Active Ingredient

    Menthol 2.0%

  • Purpose

    Topical Analgesic

  • Uses:

    • for temporary relief of minor aches and pains in muscles and joints associated with:
    • simple backaches,
    • strains
    • sprains
    • sports injuries
    • arthritis
    • bruises
  • Warnings

    FOR EXTERNAL USE ONLY

    Do not use:

    • with other topical pain relievers
    • with heating pads or heating devices

  • When using this product

    • do not use in or near 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 up and occur again within a few days
    • redness or irritation develops
  • If pregnant or breastfeeding

    ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get Medical Help or contact a Poison Control Center right away

  • Directions

    • clean affected area before applying product
    • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • Inactive Ingredients

    ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

  • PRINCIPAL DISPLAY PANEL

    Principal and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE COLD ICE ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-3021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.54 g  in 227 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    THYMOL (UNII: 3J50XA376E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AMMONIA (UNII: 5138Q19F1X)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-3021-2227 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/08/2019
    Labeler - SHIELD LINE LLC (078518916)
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