Description
LevigoLT is a Lidocaine HCI 4% and Menthol 1% topical anesthetic and analgesic cream indicated to temporarily relieve minor pain.
Levigolt
FDA Label NDC 70112-150
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 Levigolt (NDC 70112-150). 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, when using this product, ask doctor, pregnancy or breast feeding, 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
Each gram of LevigoLT contains:
Lidocaine HCI 4% (40mg) Topical Anesthetic
Menthol 1% (10mg) Topical Analgesic
Purpose
Temporarily relieves minor pain associated with: arthritis, simple backache, sprains, bruises, muscles soreness, cramps
Warnings
For external use only. Do not use on large areas of the body or on cut, irritated or swollen skin, puncture wounds, or for more than one week without consulting a doctor.
When Using This Product
When using this product use only as directed. Read and follow all directions and warnings on this carton. *was hands with soap and water after applying *rare cases of serious burns have been reported with product of this type *do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch *avoid contact with eyes and mucous membranes *atransient burning sensation may occur upon application but generally disappears in several days
Ask Doctor
Stop use and ask a doctor if *condition worsens *redness is present * irritation develops *symptoms persist 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.
Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poinson Control Center right away.
Indications & Usage
Directions: Adults and children over 12 year: *apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period *after applying, wash hands with soap and water *children 12 years or younger: ask a doctor.
Questions Or Comments
For questions or comments, call 1-800-635-3696.
Dosage And Administration
Distributed by: Topicare Therapeutics, LLC. 1925 Longmire Rd. Building 2, Conroe, TX 77304
Made in U.S.A. of U.S. and imported materials
Inactive Ingredients
Purified Water, Alcohol, Glycerin, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-13 Pareth-23, C12-13 Pareth-3, Cetearyl alcohol, Ceteth-10 phosphate, Dicetyl phosphate, Glyceryl Stearate, Caprylhydroxamic acid, 1,2-Hexanediol, Propanediol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Edetate Disodium
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from freezing.
* Please review the disclaimer below.
