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Cold Spot Point Relief by Fabrication Enterprises

Dosage form: gel
Ingredients: Menthol 115mL in 960mL, METHYL SALICYLATE 38mL in 960mL
Labeler: Fabrication Enterprises
NDC Code: 51452-001

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.

Cold Spot Point Relief Pain relieving Gel - 32 oz.

Active Ingredients: Menthol, methyl salicylate

Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

Keep out of reach of children. If swallowed consult physician

Warnings Section: 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 and if swallowed consult physician, do not bandage tightly.

pain relieving gel

Use: 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 effected area. Do not use more than four times per day.

ColdSpot Point Relief Pain Relieving spray, all natural ingredients.
COLD SPOT  POINT RELIEF
menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol115 mL  in 960 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE38 mL  in 960 mL
Inactive Ingredients
Ingredient NameStrength
water 
ARNICA CORDIFOLIA FLOWER 
CARBOMER 1342 
Ilex Paraguariensis LeaF 
Eucalyptus Globulus LEAF 
DIAZOLIDINYL UREA 
GLYCYRRHIZA GLABRA 
PROPYLPARABEN 
Peppermint Oil 
Dimethyl Sulfone 
polysorbate 80 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:51452-001-32960 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/24/2010
Labeler - Fabrication Enterprises (070577218)
Registrant - Fabrication Enterprises (070577218)
Establishment
NameAddressID/FEIOperations
Fabrication Enterprises070577218relabel
Establishment
NameAddressID/FEIOperations
pure source969241041manufacture

 
Fabrication Enterprises

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Medically reviewed on Oct 5, 2018

Further information

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

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