FDA Label for Cold Spot Point Relief

View Indications, Usage & Precautions

Cold Spot Point Relief Product Label

The following document was submitted to the FDA by the labeler of this product Fabrication Enterprises, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



menthol - usp 12%

methyl salicylate 4%


Inactive Ingredient



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, consult physician.


Warnings



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


Indications & Usage



for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.


Dosage & Administration



apply directly to affected area. do not use more than four times per day.


Otc - Purpose



for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprians.


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