Otc - Active Ingredient
Menthol 4%
Cvs Pain Relief Gel
FDA Label NDC 51316-997
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 51316-997). 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 - ask doctor, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
Temporary relief from minor aches and pains of sore muscles and joints associated with:
arthritis
backache
strains
sprains
Warnings
For external use only
Flammable: Keep away from excessive heat or open flame
Otc - Ask Doctor
Ask a doctor before use if you have: sensitive skin
Stop use and ask a doctor if
condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - When Using
When using this product
Use only as directed
Avoid contact with eyes or mucous membranes
Do not apply to wounds or damaged skin
Do not use with other ointments, creams, sprays or liniments
Do not apply to irritated skin or if excessive irritation develops
Do not bandage or use with heating pad or device
Store in a cool dry place away from direct sunlight
Wash hands after use with cool water
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)
Dosage & Administration
Directions
Adults and children 2 years of age and older: Rub a thin film over affected areas not more than daily: massage not necessary
Children under 2 years of age : Consult physician
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Dimethyl Sulphone (MSM), Glycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine, Water
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