MCM TOPICAL GEL PATCH- l-menthol patch 
FORREAL PHARMACEUTICALS LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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MCM Topical Gel Patch

Drug Facts

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only


Do not use

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Caution: This product contains natural rubber latex which may cause allergic reactions.

Directions

Adults and children 12 years of age and over:

Other Information

Inactive Ingredients

Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution, Concentrated Glycerin, Dihydroxyaluminum Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified water

PRINCIPAL DISPLAY PANEL

NDC: 81877-601-15

MCM
Topical Gel Patch

(L-Menthol 76.8 mg - Methyl Salicylate 57.6 mg - DL-Camphor 96.0 mg)

Instant Pain Relief

JOINT AND MUSCLE PAIN - SPRAINS - BACKACHE

Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE

(5 patches per pouch-3 pouches) 15 Patches

MCM Topical Gel Patch

MCM TOPICAL GEL PATCH 
l-menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL76.8 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE57.6 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96.0 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CASTOR OIL (UNII: D5340Y2I9G)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
KAOLIN (UNII: 24H4NWX5CO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GELATIN (UNII: 2G86QN327L)  
NICOTINATE ETHANOLAMINE (UNII: 71P617JXF6)  
TARTARIC ACID (UNII: W4888I119H)  
NONIVAMIDE (UNII: S846B891OR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81877-601-153 in 1 POUCH01/23/2023
15 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/23/2023
Labeler - FORREAL PHARMACEUTICALS LLC (118029197)

Revised: 1/2023
Document Id: 14e840e9-6339-4a26-a93f-edad992758b8
Set id: d40a6b1d-43fa-4f83-9542-10129ea197b0
Version: 1
Effective Time: 20230123
 
FORREAL PHARMACEUTICALS LLC