Active Ingredient
Lidocaine 4% ...... Purpose: Topical Anesthetic
Pain Relief Gel-patch
FDA Label NDC 87253-187
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Korvia Global Inc. for the product Pain Relief Gel-patch (NDC 87253-187). 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, uses, warnings, ask a doctor if:, when using this product, do not use, stop use if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses
For temporary relief of pain
Warnings
For external use only
Ask A Doctor If:
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms persists for more than 7 days
- Symptoms clear up and occur again within a few days
When Using This Product
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Do Not Use
- More than 1 patch at a time
- On wounds or damaged skin
- with a heating pad or device
- If you are allergic to any ingredients of this product
Stop Use If:
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms persists for more than 7 days
- Symptoms clear up and occur again within a few days
Pregnancy Or Breast Feeding
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 accidentally, get medical help or contact with Poison Control Center immediately.
Directions
Adult and Children 12 years of age and over:
- Clean and dry the 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 the skin after at most 8-hour application
Children under 12 years of age: Consult a doctor
Questions Or Comments?
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Edetate Disodium,Glycerin, Kaolin, Methylparaben, Polysorbate 80,Propylene Glycol, Polyacrylic Acid, Povidone K90,Propylparaben, Sodium Polyacrylate, Tartaric Acid,Titanium Dioxide, Water.
Package Label. Principal Display Panel
15-patch (87253 15)
30-patch (87253 30)
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