Otc - Active Ingredient
Active ingredients:
Lidocaine HCL 4%
Menthol 4%
Lenzapro Flex Patch
FDA Label NDC 70512-013
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 Lenzapro Flex (NDC 70512-013). 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 otc - active ingredient, otc - purpose, indications & usage, 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
Otc - Purpose
Purpose:
Topical Anesthetic
Indications & Usage
Uses:
For the temporary relief of pain
Warnings
Warnings:
For external use
Otc - Do Not Use
Do not use:
- More than 1 patch on your body at a time or on cut, iritated or swollen skin.
- On puncture wounds
- For more than 1 week without consulting a doctor
Otc - When Using
When using this product:
- Use only as directed. Read and follow all directions and warnings on this label.
- Rare cases of serious burns have been reported with products of this type.
- Do not apply to wounds or damaged, broken or irritated skin.
- Do not allow contact with the eyes and mucous membranes.
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
- Do not use at the same time as other topical analgesics.
- Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
Stop use and ask a doctor if:
- Condition worsens
- Redness is present
- Irritation developes
- Symptoms persist for more than 7 days or clear up and occur again within a few days.
- You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
Adults and children over 12 years:
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove the protective film from the patch and apply patch to the affected area.
- Reseal pouch containing unused patches after each use.
- Use 1 patch for up to 12 hours.
- Ask a doctor
Children 12 years or younger:
Other Safety Information
Other Information:
- Avoid storing product in direct sunlight
- Protect product from excessive mositure
Inactive Ingredient
Other Ingredients:
Acrylic Adhesive
Package Label.Principal Display Panel
Questions or comments? 866-747-7365
Manufactured For:
SOLA Pharmaceuticals LLC
Baton Rouge, LA 70810
NDC: 70512-013-15
QTY: 15 Articulated patches (5 per Resealable Pouch) x 3
* Please review the disclaimer below.
