Active Ingredients
Lidocaine HCL 4%
Lidocaine 4% Patch
FDA Label NDC 70512-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sola Pharmaceuticals for the product Lidocaine 4% Patch (NDC 70512-014). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy 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
Uses
For the temporary relief of pain
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:
- Clean and dry the affected area
- Open pouch and remove one patch
- Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
- Reseal pouch containing unused patches after each use
- Remove patch from the skin after at most 8-hour application
- Consult a doctor
Children under 12 years of age:
Other Information
- 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
Questions or comments? 866-747-7365
Lidocaine 4% Patch
NDC 70512-014-30
Qty: 30 Flex Patches
(5 per resealable pouch) x 6
Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810
* Please review the disclaimer below.
