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Cold Spot Point Relief by Fabrication Enterprises, inc.

Medically reviewed on October 16, 2017

Dosage form: swab
Ingredients: Menthol .96mL in 8mL
Labeler: Fabrication Enterprises, inc.
NDC Code: 51452-004

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%

aqua (deionized water), arnica montana flower (arnica) extract, chondroitin sulfate, citric acid, eucalyptus globulus oil, glucosamine sulfate,ilex paraguariensis leaf (yerba mate) extract, isopropyl alcohol, menth piperita (pepperment) oil, MSM (dimethyl sulfone) polysorbate-20, 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.

wipe onto affected area. discard wipe and clean hands after use. 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 sprains.

cold spot point relief wipes




COLD SPOT  POINT RELIEF
menthol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol.96 mL  in 8 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
BOSWELLIA SERRATA RESIN OIL 
BROMELAINS 
alcohol 
Eucalyptus Globulus leaf 
ILEX PARAGUARIENSIS LEAF 
Peppermint Oil 
Dimethyl Sulfone 
Chondroitin sulfate (bovine) 
Citric Acid 
Isopropyl Alcohol 
polysorbate 20 
Packaging
#Item CodePackage Description
1NDC:51452-004-008 mL in 1 PACKET
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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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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