FDA Label for Lidocaine 4% Patch
View Indications, Usage & Precautions
Lidocaine 4% Patch Product Label
The following document was submitted to the FDA by the labeler of this product Oncora Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Lidocaine 4%
Purpose
Topical Anesthetic
Uses
Temporarily relieves pain and itching associated with: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations.
Warnings
For external use only
Otc - Do Not Use
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
Otc - When Using
When using this product:
- Use only as directed
- Avoid contact with the eyes, mucous membranes, or rashes
- Do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if:
- Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
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
Adults and children 12 years of age or over:
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 the removal of 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 of age:Ask a physician
Other Information
Store at room temperature 15° - 30° C (59° - 86° F)
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Other Ingredients
Acrylic Adhesive, Flaxseed oil, and Polysorbate 80
Package Label.Principal Display Panel
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