Description
LevigoSP is a Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13% topical anesthetic spray indicated to temporarily relieve minor pain.
Levigosp
FDA Label NDC 70112-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topicare Management, Llc for the product Levigosp (NDC 70112-155). 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 description, active ingredients, purpose, warnings, ask doctor, when using this product, stop use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine HCL 2.5% --- Pain Reliever
Benzalkonium Chloride 0.13% --- First Aid Antiseptic
Purpose
For the temporary relief of minor pain or discomfort associated with minor: cuts, scrapes, burns, sunburn, skin irritations. First aid to prevent bacterial contamination or skin infections.
Warnings
For external use only.
Ask Doctor
Ask a doctor before use if you have: *deep or puncture wounds *animal bites *serious burns.
When Using This Product
When using this product: *use only as directed *do not use in or near the eyes *do not apply over large areas of the body *do not apply over raw surfaces or blistered areas.
Stop Use
Stop use and ask a doctor if: *condition worsens *symptoms persist for more than 7 days or clear up and occur again within a few days.
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.
Indications & Usage
Directions:
Adults and Children over 2 years: Clean the affected area, apply a small amount on the affected area 1 to 3 times daily. If bandaged, let dry first.
Children under 2 years: Ask a doctor.
Pregnant or breast feeding: Ask a doctor.
Dose & Administration
Manufactured By:
Wisconsin Pharmacal Co.
1 Pharmacal Way
Jackson, WI 53037
Made in the U.S.A. of U.S. and imported materials.
Manufactured For:
Topicare Therapeutics
1925 Longmire Rd.
Bldg. 2
Conroe, TX 77304
Net Wt. 5 FL OZ (150Ml) bottle
Questions Or Comments
For questions or comments, call 1-800-635-3696.
Inactive Ingredients
Camphor, Deionized water, Propylene Glycol
Storage & Handling
Protect from excessive heat.
* Please review the disclaimer below.
