Active Ingredients:
Menthol 10.5%
Biofreeze Spray
FDA Label NDC 59316-833
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 59316-833). 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 active ingredients:, purpose:, uses, warnings, flammable:, ask a doctor before using if you have:, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Cooling Pain Relief
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains
Warnings
For external use only.
Flammable:
Keep away from excessive heat or open flame.
Ask A Doctor Before Using If You Have:
■ 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
When Using This Product
Avoid contact with the 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; Wash hands after use with cool water; Do not use with heating pad or device; Store in a cool dry place
Stop Use And Ask A Doctor If:
Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur
If Pregnant Or Breast-Feeding:
Ask a health professional before use
Keep Out Of Reach Of Children:
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions:
Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary
Children under 12 years of age:Consult physician
Inactive Ingredients
Alcohol, Arnica Montana Flower Extract, Calendula Officinalis
Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita
(Matricaria) Flower Extract, Denatonium Benzoate, Echinacea
Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract,
Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis
Fruit Extract, Methylsulfonylmethane, Purified Water,
Tert-Butyl Alcohol
Questions Or Comments:
1-800-246-3733
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