Label: LEVIGOLT- lidocaine/menthol cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70112-150-01 - Packager: Topicare Management, LLC
- 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
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- Description
- Active Ingredients
- Purpose
- Warnings
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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
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- Pregnancy or Breast Feeding
- Keep Out of Reach of Children
- Indications & Usage
- Questions or Comments
- Dosage and Administration
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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
- Package Label. Principal Display Panel
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INGREDIENTS AND APPEARANCE
LEVIGOLT
lidocaine/menthol cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70112-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70112-150-01 1 in 1 CARTON 05/09/2017 1 76.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/09/2017 Labeler - Topicare Management, LLC (079902303) Establishment Name Address ID/FEI Business Operations Topicare Management, LLC 079902303 manufacture(70112-150)