Otc - Active Ingredient
Roll-on/Overnight Roll-on:
Menthol 4%
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Biofreeze Roll-on And Overnight Roll-on (NDC 59316-209). 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, uses, warnings, directions, other information, questions, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Roll-on/Overnight Roll-on:
Menthol 4%
Uses
Roll-on:
Temporarily relieves minor aches and pains of
muscles and joints associated with: ■ simple backache
■ arthritis ■ strains ■ bruises ■ sprains
Uses
Overnight Roll-on:
Temporarily relieves minor aches and pains of
muscles and joints associated with: ■ simple backache
■ arthritis ■ strains ■ bruises ■ sprains
Warnings
Roll-on:
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, or in conditions affecting children under 12 years
of age
Warnings
Overnight Roll-on:
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
■ children 2 years to under 12 years of age: use only under
adult supervision
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, or in conditions affecting children under 12 years
of age
Directions
Roll-on:
■ adults and children 2 years of age and older: rub a thin
film over affected area not more than 3 to 4 times daily
■ children under 2 years of age: consult a physician
■ wash hands after use with cool water
Directions
Overnight Roll-on:
■ adults and children 2 years of age and older: rub a thin
film over affected area not more than 3 to 4 times daily
■ children under 2 years of age: consult a physician
■ wash hands after use with cool water
■ store at 20-25°C (68-77°F)
■ store in a cool dry place away from direct sunlight
Questions or comments? 1-800-246-3733
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.
Purpose:
Pain Relieving Gel
Roll-on:
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock)
Extract, Arnica Montana Flower Extract, Blue 1, Boswellia
Carterii Resin Extract, Calendula Officinalis Extract, Camellia
Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex
Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl
Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract,
Silica, Tocopheryl Acetate, Triethanolamine,Water, Yellow 5
Overnight Roll-on:
Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root
Extract, Arnica Montana Flower Extract, Boswellia Carterii
Resin Extract, Calendula Officinalis Leaf Extract, Camellia
Sinensis Leaf Extract, Carbomer Interpolymer, Colloidal Silicon
Dioxide, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract,
Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified
Water, Tocopherol Acetate, Trolamine
* Please review the disclaimer below.