FDA Label for Cold And Hot Medicated Patch
View Indications, Usage & Precautions
Cold And Hot Medicated Patch 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 relieve minor aches and pains of muscles and joints due to
• simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps
Warnings
EXTERNAL USE ONLY
When Using
• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.
Stop Use
• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
Adults and Children 12 years of age and older:
• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 to 4 times daily
Children under 12 years of age: Consult a doctor.
Other Information
• store at room temperature 68° to 77°F (20° to 25°C)
*Compare to the active ingredient in Icy Hot® Patch
EXTRA STRENGTH
Contains Menthol 5%
Pain relieving ointment on a breathable adhesive pad
EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove.
FAST RELIEF OF MINOR ACHES AND PAINS
*This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.
Distributed By:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
MADE IN CHINA
www.universaldc.com
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions
www.universaldc.com
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