FDA Label for Hot/cold Medicated Patch
View Indications, Usage & Precautions
Hot/cold Medicated Patch Product Label
The following document was submitted to the FDA by the labeler of this product Dynarex. 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
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
- sypmtoms 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 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
Children under 12 years of age, consult a doctor
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
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