Otc - Active Ingredient
Menthol 4%
Cvs Pain Relief Gel
FDA Label NDC 51316-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Pain Relief (NDC 51316-161). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Indications & Usage
Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains, bruises, and muscle strains.
Warnings
For external use only.
Flammable. Keep away from excessive heat or open flame.
When using this product use only as directed. Avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin, do no apply to irritated skin or if excessive irritation develops, do not bandage tightly or use with heating pad or device. Children 12 years of age and older: use only under adult supervision.
Stop use and ask a doctor if you experience pain, swelling, or blistering of the skin, condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children of 12 years: rub a thin film over affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. Wash hands after use with cool water.
Inactive Ingredient
Carbomer, fragrance, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water.
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