COLD SPOT POINT RELIEF- menthol gel

Cold Spot by

Drug Labeling and Warnings

Cold Spot by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises, inc. , Pure Source . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD SPOT  POINT RELIEF
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.4 mL  in 120 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4.8 mL  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
BROMELAINS (UNII: U182GP2CF3)
CARBOMER 1342 (UNII: 809Y72KV36)
Eucalyptus Globulus leaf (UNII: S546YLW6E6)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
Peppermint Oil (UNII: AV092KU4JH)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
alcohol (UNII: 3K9958V90M)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/13/2011

Labeler - Fabrication Enterprises, inc. (070577218)

Registrant - Pure Source (969241041)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture