Otc - Active Ingredient
Active ingredient:
Menthol 15%
Purpose:
Pain Relieving Stick
Biofreeze Dry Stick
FDA Label NDC 59316-230
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 Dry Stick (NDC 59316-230). 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, uses, warnings, otc - keep out of reach of children, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredient:
Menthol 15%
Purpose:
Pain Relieving Stick
Uses
Uses:
Temporarily relieves minor aches and pains of muscles and joints associated with:
■ simple backache
■ arthritis
■ strains
■ bruises
■ sprains
Warnings
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
Directions
■ adults and children 12 years of age and older: turn dial and apply a thin
film by rubbing 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 Safety Information
Other information
■ store at 20-25°C (68-77°F)
■ store in a cool dry place away from direct sunlight
Inactive Ingredient
Inactive ingredients
alpha-tocopherol acetate, arachidic acid, c15-19 alkane, hydrogenated
castor oil, lauric acid, linoleic acid, linolenic acid, menthyl ethylamido oxalate,
myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, stearic acid
Otc - Questions
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