MCM TOPICAL GEL PATCH- l-menthol patch

MCM Topical Gel Patch by

Drug Labeling and Warnings

MCM Topical Gel Patch by is a Otc medication manufactured, distributed, or labeled by FORREAL PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

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

• Arthritis
• Simple backache
• Strains
• Bruises
• Sprains

WARNINGS

Warnings

For external use only

Do not use

• On wounds or damaged skin
• If you are allergic to aspirin or salicylates
• With a heating pad
• With, or at the same time as other external analgesic products

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

When using this product

• Do not use other than directed
• Avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

• Rash, itching, or excessive skin irritation develops
• Condition worsens
• Symptoms persist for longer than 7 days
• Symptoms clear up and reoccur within a few days

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.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and over:

• Clean and dry affected area
• Remove patch from film
• Apply to affected area no more than 3 to 4 times daily for 7 days
• Remove patch from skin after at most 8 hours of application
• Children under 12 years of age: Consult a doctor

OTHER SAFETY INFORMATION

Other Information

• Avoid storing product in direct sunlight
• Protect from excessive moisture

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

MCM TOPICAL GEL PATCH 
l-menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81877-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	76.8 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	57.6 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	96.0 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81877-601-15	3 in 1 POUCH	01/23/2023
1		5 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/23/2023

Labeler - FORREAL PHARMACEUTICALS LLC (118029197)