Active Ingredient
Menthol 4%
Free And Pure Cold Therapy Pain Relief Gel
FDA Label NDC 0363-0383
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Free And Pure Cold Therapy Pain Relief (NDC 0363-0383). 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, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, 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
Purpose
Topical analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joing 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 yes or on mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritate 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
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 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: do not use, 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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia SErrata Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Silicon Dioxide, Tocopheryl Acetate, Water
* Please review the disclaimer below.
