COLD SPOT POINT RELIEF- menthol swab

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%

INACTIVE INGREDIENT

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

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

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

PRINCIPAL DISPLAY PANEL

cold spot point relief wipes

INGREDIENTS AND APPEARANCE

COLD SPOT  POINT RELIEF
menthol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	.96 mL  in 8 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
BROMELAINS (UNII: U182GP2CF3)
alcohol (UNII: 3K9958V90M)
Eucalyptus Globulus leaf (UNII: S546YLW6E6)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
Peppermint Oil (UNII: AV092KU4JH)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
Chondroitin sulfate (bovine) (UNII: 6IC1M3OG5Z)
Citric Acid (UNII: 2968PHW8QP)
Isopropyl Alcohol (UNII: ND2M416302)
polysorbate 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-004-00	8 mL in 1 PACKET

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