Active Ingredients
Lidocaine 4% w/w ...... Purpose: Topical Anesthetic
Menthol 1% w/w ...... Purpose: Topical Analgesic
Pain Relief Gel-patch
FDA Label NDC 83016-171
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by R & Y Group, Llc for the product Pain Relief Gel-patch (NDC 83016-171). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, when using this product, stop use and consult a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
01 (83016 171 01)
07 (83016 171 07)
* Please review the disclaimer below.
