Active Ingredient
Lidocaine 4%
Universal Pain Relief Patch
FDA Label NDC 52000-407
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Universal Pain Relief (NDC 52000-407). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
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
When using this product: • Use only as directed • Avoid contact with the eyes, mucous membranes or rashes • Do not bandage tightly
Stop use and 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
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adult and Children 12 years of age and over:
- Clean and dry affected area
- Remove film from patch and apply to the skin (see illustration)
- 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
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water
Packaging
Painreliever01 (5200040702)
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