FDA Label for Pain Relief Hot Patch
View Indications, Usage & Precautions
Pain Relief Hot 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 3%
Capsaicin 0.083%
Purpose
Topical Analgesic
Use
Temporarily relieves minor pain associated with:
arthritis • simple backache • bursitis • tendonitis • muscle strains • 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
STOP USE and ask a doctor if • 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:
• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
• Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: DO NOT use without consulting a doctor.
Other Information
For fast relief of minor aches and pains due to:
• Arthritis
• Strains
• Bruises
• Sprains
EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.
FAST-ACTING PAIN RELIEF
Distributed by:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
MADE IN CHINA
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
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