VITACIN- methyl salicylate, menthol, capsaicin cream 
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 Ingredient:

Methyl Salicylate                     20.00%                                        Topical Analgesic

Menthol                                    5.00%                                        Topical Analgesic

Capsaicin                                  0.0375%                                    Topical Analgesic

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

Keep out of reach of children. If swallowed, consult physician.

VitaCin

(Capsaicin - Methyl Salicylate - Menthol)

Directions:

Warnings:

For external use only. 

Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Do not apply to wounds or damaged skin.

Do not bandage tightly.

If pregnant or breast feeding, contact physician prior to use.

Other Ingredients:

aqua (deionized water), arnica montana flowe rextract, C13-14 isoparaffin, cetearyl alcohol, chondroitin sulfate, emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, methylsulfonylmethane (MSM), PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, triethanolamine, urea.

image description

VITACIN 
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69677-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69677-010-01120 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/2015
Labeler - MAS Management Group Inc. (079363782)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, Inc.969241041manufacture(69677-010)

Revised: 7/2015
Document Id: e8d56ba8-1a13-4b50-b14b-8c97a185063a
Set id: c8eda77c-2b0d-46f8-80a6-219f7b97e07d
Version: 1
Effective Time: 20150702
 
MAS Management Group Inc.