FDA Label for Hot Cold Medicated Patches
View Indications, Usage & Precautions
Hot Cold Medicated Patches Product Label
The following document was submitted to the FDA by the labeler of this product Henan Enokon Medical Instrument Co., Ltd.. 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 associated with:■simple backache■arthritis■ strains■bruises ■sprains
Warnings
For external use only
Do Not Use
■ on wounds or damaged skin with a heating pad
■ if you have ever had an allergic reaction to this product or any of its ingredients
When Using
When using this product
■ use only as directed
■ avoid contact with the eyes mucous membranes or rashes ■ do not bandage tightly
Stop Use
Stop use and ask a doctor if
■ localized skin reactions occur, such as rash, itching, redness, irritation pain swelling and blistering
■ conditions worsen
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
Ask Doctor
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
■ remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor
Other Information
■ avoid storing product in direct sunlight
■ protect product from excessive moisture
■ store at 20-25°C(68-77°F)
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions
Call 718-975-2586
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