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LevigoLT

Medically reviewed on May 25, 2017

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE 4g in 100g, MENTHOL 1g in 100g
Labeler: Topicare Management, LLC
NDC Code: 70112-150

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Description

LevigoLT is a Lidocaine HCI 4% and Menthol 1% topical anesthetic and analgesic cream indicated to temporarily relieve minor pain.

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.

Package Label. Principal Display Panel

LEVIGOLT 
lidocaine/menthol cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70112-150
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLYSORBATE 20 
SODIUM HYDROXIDE 
WATER 
CETETH-10 PHOSPHATE 
EDETATE DISODIUM 
DIHEXADECYL PHOSPHATE 
ALOE VERA LEAF 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
GLYCERYL MONOSTEARATE 
1,2-HEXANEDIOL 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 
GLYCERIN 
C12-13 PARETH-23 
PROPANEDIOL 
CAPRYLHYDROXAMIC ACID 
C12-13 PARETH-3 
CETOSTEARYL ALCOHOL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70112-150-011 TUBE in 1 CARTON
176.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/09/2017
Labeler - Topicare Management, LLC (079902303)
Establishment
NameAddressID/FEIOperations
Topicare Management, LLC079902303manufacture(70112-150)

 
Topicare Management, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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