FDA Label for Pain Relief Gel-patch
View Indications, Usage & Precautions
Pain Relief Gel-patch Product Label
The following document was submitted to the FDA by the labeler of this product R & Y Group, Llc. 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 Ingredients
Lidocaine 4% w/w ...... Purpose: Topical Anesthetic
Menthol 1% w/w ...... Purpose: Topical Analgesic
Purpose
Topical Anesthetic (Lidocaine)
Topical Analgesic (Menthol)
Use
for temporary relief of pain
Warnings
For External Use Only
Do Not Use
- More than 1 patch at a time
- If you are allergic to any ingredients of this product
- On wounds or damaged skin
- In large quantities, particularly over raw surfaces or blistered areas
When Using This Product
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Stop Use And Consult A Doctor If
- Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms clear up and occur again within a few days
- Symptoms persist for more than 7 days
If Pregnant Or Breast-Feeding,
ask a physician 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 to affected area not more than 3 to 4 times daily
- Remove patch from the skin after 8-hour application at most
Children under 12 years of age: Consult a physician
Other Information
- Store at 68° - 77° F (20° - 25° C)
- Store in a cool dry place away from direct sunlight
Inactive Ingredients
Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water
Package Label. Principal Display Panel
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