VITACIN- methyl salicylate, menthol, capsaicin cream 
Pure Source, LLC

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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:65121-302
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:65121-302-01120 g in 1 PACKAGE; Type 0: Not a Combination Product06/10/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/10/2015
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(65121-302)

Revised: 11/2023
Document Id: 0abe5f3b-4b5b-8b18-e063-6394a90a9934
Set id: 4ea5773b-1da0-41d7-afce-8a6ab72f630a
Version: 3
Effective Time: 20231122
 
Pure Source, LLC