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Drug Facts
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
Biofreeze Gel
FDA Label NDC 59316-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Biofreeze (NDC 59316-122). 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 other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, 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
Active Ingredient
Camphor 6%
Capsaicin 0.05%
Menthol 10%
Purpose
Pain Relieving Gel
Uses
Uses
Temporarily relieves minor aches and
pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
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 the eyes or on mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritated skin or if excessive irritation develops
- do not bandage tightly or use with heating pad or device
Stop Use And Ask A Doctor If
- you experience pain, swelling or blistering of the skin
- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
- arthritic pain persists for more than 10 days, or redness is present
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
- children under 12 years of age: consult a physician
- wash hands after use with cool water
Other Information
- store at 20-25°C (68-77°F)
- store in a cool dry place away from direct sunlight
Inactive Ingredients
1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Alcohol, Caprylyl Glycol, Carbomer,
Denatonium Benzoate, Ethylhexylglycerin, Glycerin,
Menthyl Ethylamido Oxalate, Phenoxyethanol,
Propanediol, Purified Water, Steareth-2,
Steareth-21, T-Butyl Alcohol, Tetrasodium
Glutamate Diacetate, Trolamine
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