Active Ingredient
Lidocaine 4%
Lidocaine 4 Percent Patch
FDA Label NDC 71436-3104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ari Brands, Llc for the product Lidocaine 4 Percent (NDC 71436-3104). 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, do not use, when using this product, stop use and ask a physician:, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
Temporarily relieves pain and itching associated with:
• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations
Warnings
For external use only.
Read all warnings and directions before use.
Do Not Use
• More than one patch at a time
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product
Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.
When Using This Product
• Use only as directed.
• Avoid contact with eyes, mucous membranes, or rashes
• Do not tightly wrap or bandage the treated area
Stop Use And Ask A Physician:
• If pregnant or breast feeding
• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 12 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 12 years: Ask a physician
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Avoid storing product in direct sunlight and protect product from excessive moisture.
Inactive Ingredients
Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminum Aminoacetate, Methylparaben, Peppermint Oil
Principal Display Panel
Lidocaine 4% Patch
NDC 71436-3104-1
10 Patches per Box
AriBrands, LLC
Lidocaine 4% Patchndc 71436-3104-110 Patches Per Boxaribrands, Llc (Lidocaine Patch 01)
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