Label: MOUNTAIN ICE PAIN RELIEF- menthol gel

  • NDC Code(s): 72793-100-01, 72793-100-02, 72793-100-03, 72793-100-04, view more
    72793-100-05
  • Packager: Mountainside Medical Equipment, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • Active ingredients:

    Menthol 5%

  • Purpose

    External Analgesic

  • Uses

    Temporary relief of minor aches and pains of muscles and joints associated with osteoarthritis, rheumatoid arthritis, muscle strains, and sprains

  • Warnings

    For external use only.

    Flammable; keep away from excessive heat or open flame. Avoid contact with eyes or mucous membranes.

    When using this product:

    •
    Do not apply to wounds, damaged skin, or irritated skin.
    •
    Do not apply with other creams, ointments, sprays or liniments.
    •
    Stop use and ask a doctor if: Conditions worsen, skin irritation develops, or condition does not improve after 7 days.

    Keep out the reach of children:

    If accidentally swallowed seek medical attention immediately or contact Poison Control Center right away.

  • Directions:

    Adults and Children 2 years of age or older: Rub on the affected area evenly no more than 4 time. Children under 2 years of age: Consult with your doctor.

  • Inactive Ingredients:

    Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Carbomer, Cinnamomum Camphora (Camphor) Bark Oil, Curcuma longa (Turmeric) Root Oil, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine HCl, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propanediol, Sodium Chondroitin Sulfate, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water (Aqua), Blue 1 (CI 42090).

  • Package/Label Principal Display Panel – Tube Label

    Arthritis Pain Relieving Gel

    MOUNTAIN ICE

    Tumeric, Glucosamine, Chondroitin, Methylsulfonylmethane (MSM), Camphor, Menthol 5%, Arnica Montana, Aloe Vera, Tea Tree Oil, Hyaluronic acid, Vitamin E, Ilex Paraguariensis Leaf Extract.

    4 fl oz (118 mL)

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    MOUNTAIN ICE  PAIN RELIEF
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72793-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72793-100-01118 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2019
    2NDC:72793-100-0230 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/28/201906/14/2022
    3NDC:72793-100-03946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/06/2019
    4NDC:72793-100-046 mL in 1 PACKET; Type 0: Not a Combination Product12/06/2019
    5NDC:72793-100-0599 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/28/2019
    Labeler - Mountainside Medical Equipment, Inc. (119735871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(72793-100)
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