Active Ingredient
Menthol 4%
Equate Cold Therapy Pain Relieving Gel
FDA Label NDC 79903-021
9 label sections · Submitted to the FDA by Wal-mart Stores, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Equate Cold Therapy Pain Relieving (NDC 79903-021). 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 ingredient, purpose, uses, when using this product, flammable, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains
When Using This Product
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pads or other heating devices
Flammable
- keep away from fire or flame
Directions
adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.
Inactive Ingredients
aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.
Questions Or Comments?
1-888-287-1915
Principal Display Panel - 89 Ml Tube Label
NDC 79903-021-01
equate™
Compare
to Biofreeze®
active
ingredient*
Cold Therapy
Pain Relieving
Gel
Menthol 4% Topical
Analgesic
- For backache, muscle
pain, joint pain - Soothing menthol
3 FL OZ (89mL)
Principal Display Panel (89 mL Tube Label)
* Please review the disclaimer below.
