MENTHOL, CAPSAICIN- vitacin patch

Menthol, Capsaicin by

Drug Labeling and Warnings

Menthol, Capsaicin by is a Otc medication manufactured, distributed, or labeled by MAS Management Group Inc., MAS MANAGEMENT GROUP INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol 5%

PURPOSE

External Analgesic

USES

For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.

WARNINGS

• For external use only.
• Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Do not cover with bandage.
• Do not use on wounds or damaged skin.
• Do not use in combination with any other external analgesic products.
• Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.

Keep out of reach of children

Consult physician for children under 12.

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

Pregnancy or Breast Feeding

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

DIRECTIONS

• Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
• Children under 12years, consult physician before use
• Clean and dry affected area
• Remove protective film and apply directly to area of pain
• Apply to affected area not more than 3 times daily
• Wash hands with soap after applying patch
• Reseal pouch containing unused patches

INACTIVE INGREDIENTS

WATER, GLYCERINE, SODIUM POLYACRYLATE, POLYSORBATE 80, ALOE BARBADESIS LEAF (ALOE VERA
GEL) JUICE, EDTA DISODIUM SALT, DIAZOLIDINYL UREA, METHYLPARABEN, LODOPROYNYL BUTYLCABAMATE, PROPYLPARABEN.

Storage and Handling

Store in dry area between 59-79 F(15-26 C)

Questions or Comments

Please call (800) 768-3518

DOSAGE & ADMINISTRATION

Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.

Children under 12years, consult physician before use.

VitaCin Patch

INGREDIENTS AND APPEARANCE

MENTHOL, CAPSAICIN 
vitacin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69677-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.375 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69677-011-15	15 in 1 BOX	09/01/2016
1		8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2016

Labeler - MAS Management Group Inc. (079363782)

Establishment
Name	Address	ID/FEI	Business Operations
MAS MANAGEMENT GROUP INC.		079363782	label(69677-011)