FDA Label for Mountain Ice Pain Relief
View Indications, Usage & Precautions
Mountain Ice Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Mountainside Medical Equipment, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
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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