MENCAINE- lidocaine, menthol patch 
Neptune Products

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.

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Mencaine

Active Ingredients (in each patch):

Lidocaine 4.5% Topical Anesthetic

Menthol 5% Topical Analgesic

USES:

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

WARNINGS:

For external use only

This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you:

Do not use:

Ask a doctor before use if:

When using this product:

Stop use and consult your physician if:

If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children, if put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

Adults, or children over the age of 12:

Apply patch to affected are 1 to 2 times daily or as directed

Children under 12 years of age:

Do not use

INSTRUCTIONS FOR USE:

OTHER INFORMATION:

INACTIVE INGREDIENTS:

Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerine, Kaolin, Partially Neutralized Polyacrylate, Phenoxyethanol, Polysorbate 80, Polyvinyl Pyrrolidone, Tartaric Acid, Tetrasodium EDTA, Water

mencaine

box 1090-5

MENCAINE 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72594-1090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.5 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)  
.ALPHA.-ISOBUTYLPHENETHYL ALCOHOL (UNII: 2SBL0E1I0N)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72594-1090-11 mg in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug11/08/2022
2NDC:72594-1090-55 in 1 BOX11/08/2022
23 in 1 POUCH
28500 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/08/2022
Labeler - Neptune Products (081502369)

Revised: 8/2023
Document Id: 02ac4acc-581c-1b83-e063-6294a90a97eb
Set id: ecf97400-2d61-0577-e053-2a95a90adb0f
Version: 2
Effective Time: 20230803
 
Neptune Products