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Cold Spot Point Relief by Fabrication Enterprises, inc.

Medically reviewed on October 13, 2017

Dosage form: gel
Ingredients: MENTHOL 14.4mL in 120mL, METHYL SALICYLATE 4.8mL in 120mL
Labeler: Fabrication Enterprises, inc.
NDC Code: 51452-005

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.

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.

COLD SPOT  POINT RELIEF
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL14.4 mL  in 120 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE4.8 mL  in 120 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
BOSWELLIA SERRATA RESIN OIL 
BROMELAINS 
CARBOMER 1342 
Eucalyptus Globulus leaf 
ILEX PARAGUARIENSIS LEAF 
Peppermint Oil 
Dimethyl Sulfone 
GLYCYRRHIZA GLABRA 
alcohol 
DIAZOLIDINYL UREA 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
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/FEIOperations
Pure Source 969241041manufacture

 
Fabrication Enterprises, inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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