Active Ingredient
Lidocaine 4%
Pain Relief Gel-patch
FDA Label NDC 69396-134
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Pain Relief Gel-patch (NDC 69396-134). 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 ingredient, purpose, indications & usage, warnings, stop use and ask a doctor, keep out of the reach of children, do not use, 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
Indications & Usage
For temporary relief of pain
Warnings
For External Use Only
Stop Use And Ask A Doctor
- Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Condition worsens
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
- More than 1 patch at a time
- On wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
If Pregnant Or Breast-Feeding
Ask a health professional before use
When Using This Product
- Use only as directed
- Avoid contact with eyes, mucous membranes or rashes
- Do not bandage tightly
Directions
Adult 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 teh skin after at most 8-hour application
- Children under 12 years of age. Consult a doctor
Other Information
- Store at controlled room temperature 68°-77°F (20°-25°C)
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.
Questions Or Comments
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 4802
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