Cold Spot Point Relief

Generic Name: menthol
Dosage Form: ointment

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 Roll On - 3 oz.

Active Ingredients: Menthol

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 relief

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 ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 13 mL  in 90 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ARNICA CORDIFOLIA FLOWER  
CHONDROITIN SULFATE (BOVINE)  
EUCALYPTUS GLOBULUS LEAF  
GLUCOSAMINE SULFATE  
ILEX PARAGUARIENSIS LEAF  
CARBOMER 1342  
peppermint oil  
DIMETHYL SULFONE  
POLYSORBATE 20  
ALCOHOL  
Packaging
# Item Code Package Description
1 NDC:51452-002-03 90 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/24/2010
Labeler - Fabrication Enterprises (070577218)
Registrant - Fabrication Enterprises (070577218)
Establishment
Name Address ID/FEI Operations
Fabrication Enterprises 070577218 relabel
Establishment
Name Address ID/FEI Operations
pure source 969241041 manufacture
Revised: 10/2010
 
Fabrication Enterprises



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