FDA Label for Cold And Hot Medicated
View Indications, Usage & Precautions
Cold And Hot Medicated Product Label
The following document was submitted to the FDA by the labeler of this product The Mentholatum Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 5%
Purpose
Menthol - Topical analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints due to
• arthritis• simple backache• strains• sprains• bursitis• tendonitis• bruises• cramps
Warnings
For external use only
When Using This Product
• use only as directed• avoid contact with eyes or on mucous membranes• do not apply to wounds or to damaged or very sensitive skin• do not bandage tightly or use with a heating pad
Stop Use And Ask A Doctor If
• excessive redness or irritation is present• condition worsens• pain persist for more than 7 days• symptoms clear up and occur again within a few days
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 12 years and over: apply patch to affected area as needed but not more than 4 times daily• children under 12 years: ask a doctor• for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.
Inactive Ingredients
carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid
* Please review the disclaimer below.