Cold Spot description, usages, side effects, indications, overdosage, supplying and lots more!

Cold Spot

Fabrication Enterprises, inc.
Pure Source

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
coldspot point relief



FULL PRESCRIBING INFORMATION

Active ingredient

menthol - usp 12%

methyl salicylate 4%

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

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

Uses

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

Purpose

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

Cold Spot

MENTHOL GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51452-005
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 14.4 mL
methyl salicylate METHYL SALICYLATE 4.8 mL

Inactive Ingredients

Ingredient Name Strength
water
ARNICA MONTANA FLOWER
BOSWELLIA SERRATA RESIN OIL
BROMELAINS
CARBOMER 1342
EUCALYPTUS GLOBULUS LEAF
ILEX PARAGUARIENSIS LEAF
PEPPERMINT OIL
DIMETHYL SULFONE
GLYCYRRHIZA GLABRA
ALCOHOL
DIAZOLIDINYL UREA
METHYLPARABEN
polysorbate 80
propylene glycol
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51452-005-04 4 in 1 TUBE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-10-13


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