Active Ingredient
Menthol 5%
Cold/hot Medicated Patches
FDA Label NDC 67777-145
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Cold/hot Medicated Patches (NDC 67777-145). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Use
Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, strains, sprains, bruises
Warnings
For external use only
Do Not Use
on wounds or damaged skin, with a heating pad, if you are allergic to any ingredients of this product
When Using This Product
use only as directed, avoid contact with the eyes, mucous membranes or rashes
Stop Use And Ask A Doctor If
- excessive redness or irritation is present
- conditions worsen
- symptoms 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.
Otc - 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 of age and over
- clean and dry affected area
- remove film from patch and apply to the skin
- apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- wear each patch up to 8 hours maximum
- consult a doctor
Children under 12 years of age
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.
* Please review the disclaimer below.
