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Cold Spot Point Relief by Pure Source

Medically reviewed on August 28, 2017

Dosage form: gel
Ingredients: MENTHOL 58mL in 480mL, MENTHYL SALICYLATE 19mL in 480mL
Labeler: Pure Source
NDC Code: 65121-001

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 - 16 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.

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 gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL58 mL  in 480 mL
MENTHYL SALICYLATE (SALICYLIC ACID) MENTHYL SALICYLATE19 mL  in 480 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA CORDIFOLIA FLOWER 
CARBOMER 1342 
DIAZOLIDINYL UREA 
Eucalyptus Globulus LEAF 
GLYCYRRHIZA GLABRA 
Ilex Paraguariensis LeaF 
PROPYLPARABEN 
Peppermint Oil 
Dimethyl Sulfone 
polysorbate 80 
ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:65121-001-16480 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/24/2010
Labeler - Pure Source (969241041)
Registrant - Pure Source (969241041)
Establishment
NameAddressID/FEIOperations
Pure Source969241041manufacture

 
Pure Source

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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