MENTHOL, CAPSAICIN- vitacin patch 
MAS Management Group Inc.

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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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

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

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

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

Vitacin Patch

MENTHOL, CAPSAICIN 
vitacin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69677-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.375 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69677-011-1515 in 1 BOX09/01/2016
18 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2016
Labeler - MAS Management Group Inc. (079363782)
Establishment
NameAddressID/FEIBusiness Operations
MAS MANAGEMENT GROUP INC.079363782label(69677-011)

Revised: 8/2016
Document Id: 3b4d9084-612c-1049-e054-00144ff8d46c
Set id: 3b4d9084-612b-1049-e054-00144ff8d46c
Version: 1
Effective Time: 20160830
 
MAS Management Group Inc.