Label: LEVIGOLT- lidocaine/menthol cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 25, 2017

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    LEVIGOLT 
    lidocaine/menthol cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70112-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C12-13 PARETH-23 (UNII: J1WW1510L4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    C12-13 PARETH-3 (UNII: DMC6N3419L)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70112-150-011 in 1 CARTON05/09/2017
    176.5 g in 1 TUBE; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    Topicare Management, LLC079902303manufacture(70112-150)