Oars And Alps Muscle Recovery Balm Cream
FDA Label NDC 52261-6300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc for the product Oars And Alps Muscle Recovery Balm (NDC 52261-6300). 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 drug facts, uses:, warnings:, otc - keep out of reach of children, otc - do not use, otc - ask doctor, indications & usage, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Menthol - 5%....................................External Analgesic
Methyl Salicylate (NSAID) – 10%.........External Analgesic

Uses:

For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation

Warnings:

For external use only.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Do Not Use

Do not use on wounds or damaged skin, with a heating pad, on a child under 12 years of age with arthritis-like condition.

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Indications & Usage

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs

Directions:

Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
Children under 12 years of age: ask a doctor before use.

Inactive Ingredients:

Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Carbomer, Cetostearyl Alcohol, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexylglycerin, Octyl Palmitate, Fragrance, Glucosamine, Glyceryl Monostearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Turmeric Oil, Water

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat

Allergy Alert:

Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

* Please review the disclaimer below.