Mountain Ice Gel
FDA Label NDC 72793-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mountainside Medical Equipment, Inc. for the product Mountain Ice (NDC 72793-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose, uses, warnings, when using this product:, keep out the reach of children:, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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).

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 (Image 01)

Image-01 (Image 01)

Label

Package/Label Principal Display Panel – Bottle 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.

1 fl oz (30 mL)

Label

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