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
  • Marketing Status: OTC monograph not final

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 October 28, 2021

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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

    Distributed by: Crown Laboratories, Inc.

    Johnson City, TN 37604 ©2018 Made in Canada.

    ORIGINAL THERAPEUTIC

    Mineral Ice ®

    Menthol Pain Relieving Gel

    Greaseless with DEEPCOLD ® Pain Reliever

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

  • Principal Display

    0316-0226-08

    Mineral Ice®

    Menthol Pain Relieving Gel

    Greaseless with DEEPCOLD® Pain Reliever

    Net wt. 8 oz (226.8 g)

    Distributed by: Crown Laboratories, Inc.

    Johnson City, TN 37604

    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 not finalpart34811/01/2011
    Labeler - Crown Laboratories (079035945)
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