COLD SPOT POINT RELIEF - menthol gel 
Fabrication Enterprises, 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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coldspot point relief

menthol - usp 12%

methyl salicylate 4%

aqua (deionized water), arnica montana flower (arnica) extract, boswella serrata extract, brtomelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, menth piperita (pepperment) oil, methyl paraben, MSM (dimethyl sulfone) polysorbate-80, SD-alcohol 40B, triethanolamine

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

for external use only

avoid contact with eyes

do not apply to open wounds or damaged skin

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

keep out of reach of children. if swallowed, consult physician

do not bandage tightly

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

apply directly to affected area. do not use more than four times per day.

for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprians.

carton label

COLD SPOT  POINT RELIEF
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.4 mL  in 120 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE4.8 mL  in 120 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
BROMELAINS (UNII: U182GP2CF3)  
CARBOMER 1342 (UNII: 809Y72KV36)  
Eucalyptus Globulus leaf (UNII: S546YLW6E6)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
Peppermint Oil (UNII: AV092KU4JH)  
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
alcohol (UNII: 3K9958V90M)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51452-005-044 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/13/2011
Labeler - Fabrication Enterprises, inc. (070577218)
Registrant - Pure Source (969241041)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source 969241041manufacture

Revised: 10/2011
Document Id: 5a2a8dbf-7614-4b9c-a662-65a472413df0
Set id: 28b9127e-d9bc-4da4-8444-07246ebe4a62
Version: 4
Effective Time: 20111013
 
Fabrication Enterprises, inc.