Label: MINERAL ICE- menthol gel

  • NDC Code(s): 61047-202-01, 61047-202-02, 61047-202-03
  • Packager: Voyant Beauty, Inc.
  • 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 December 31, 2020

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

  • SPL UNCLASSIFIED SECTION

    MINERAL ICE

    DRUG FACTS

  • Active Ingredients

    Menthol 2%

  • Purpose

    Topical analgesic

  • Uses

    • Temporarily relieves minor aches and pains of muscles and joints associated with:
    • Arthritis
    • simple backache
    • strains
    • Bruises
    • sport injuries
    • 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 yes
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly

    Stop use and ask a doctor if

    • Conditions worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days
    • Redness or irritation develops

    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
    • Adults and children 2 years of age and older: apply in affected area not more than 3 to 4 times daily
    • Children under 2 years of age, ask a doctor
  • Other information

    • Store at controlled temperature 20 to 25C (68-77F) in a tightly cleaned container
    • 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/comments?

    1-855-328-5258

  • PRINCIPAL DISPLAY PANEL 3.5 oz (99.2g)

    NDC 0067-2067-35

    Original Theraputic

    MINERAL

    ICE

    Greaseless

    Net Wt 3.5 oz (99.2 g)

    3.5 oz Jar

  • PRINCIPAL DISPLAY PANEL 8 oz (226.8g)

    NDC 0067-2067-08

    Original Theraputic

    MINERAL

    ICE

    Greaseless

    Net Wt 8 oz (226.8 g)

    8 oz Jar

  • PRINCIPAL DISPLAY PANEL 16oz (453.6g)

    NDC 0067-2067-16

    Original Theraputic

    MINERAL

    ICE

    Greaseless

    Net Wt 16 oz (453.6 g)

    16oz Jar

  • INGREDIENTS AND APPEARANCE
    MINERAL ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61047-202-0199.2 g in 1 JAR; Type 0: Not a Combination Product02/10/2016
    2NDC:61047-202-02226.8 g in 1 JAR; Type 0: Not a Combination Product02/09/2016
    3NDC:61047-202-03453.6 g in 1 JAR; Type 0: Not a Combination Product02/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/08/2016
    Labeler - Voyant Beauty, Inc. (243547333)