Label: MINERAL ICE PAIN RELIEVING- menthol gel

  • NDC Code(s): 0316-0226-08, 0316-0226-16, 0316-0226-35
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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  • Active ingredient

    Menthol 2%

  • Purpose

    Topical analgesic

  • Uses

    ● temporarily relieves minor aches and pains of muscles and joints associated with:

    ● arthritis ● simple backache ● strains

    • ● bruises ● sprains

    ● provides cooling penetrating relief

  • 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 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 up and occur again within a few days

    If pregnant or breast-feeding,

    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
    • children under 2 years of age: ask a doctor
  • Other information

    • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature], in a tightly closed container
    • store in a cool place
    • do not use, pour, spill or store near heat or open flame
  • Inactive ingredients

    ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

  • Questions or comments?

    call 1-833-279-6522

  • Additional Information Listed on Other Panels

    1-833-279-6522 ©Crown Laboratories, Inc.

    Distributed by: Crown Laboratories, Inc.

    Johnson City, TN 37604 ©2018 Made in Canada.

    Mineral Ice and the Mineral Ice mountain range are registered trademarks of Crown Laboratories, Inc.

  • Principal Display

    NDC 0316-0226-08

    ORIGINAL THERAPEUTIC

    Mineral Ice®

    Menthol Pain Relieving Gel

    Greaseless with DEEPCOLD® Pain Reliever

    Net wt. 8 oz (226.8 g)

    P11529.00

    p1152900

  • INGREDIENTS AND APPEARANCE
    MINERAL ICE  PAIN RELIEVING
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0226
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0226-3599.2 g in 1 JAR; Type 0: Not a Combination Product12/01/2018
    2NDC:0316-0226-08226.8 g in 1 JAR; Type 0: Not a Combination Product12/01/2018
    3NDC:0316-0226-16453.6 g in 1 JAR; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2011
    Labeler - Crown Laboratories (079035945)
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