COLD SPOT POINT RELIEF- menthol, methyl salicylate gel

Cold Spot by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Menthol, methyl salicylate

INACTIVE INGREDIENT

Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed consult physician

WARNINGS

Warnings Section: 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 and if swallowed consult physician, do not bandage tightly.

PURPOSE

pain relieving gel.

INDICATIONS & USAGE

Use: 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 effected area. Do not use more than four times per day.

PRINCIPAL DISPLAY PANEL

ColdSpot Point Relief Pain Relieving spray, all natural ingredients.

INGREDIENTS AND APPEARANCE

COLD SPOT  POINT RELIEF
menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14 mL  in 120 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	5 mL  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA CORDIFOLIA FLOWER (UNII: JCG1OSZ7A8)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CARBOMER 1342 (UNII: 809Y72KV36)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
polysorbate 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-001-04	120 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/24/2010

Labeler - Fabrication Enterprises (070577218)

Registrant - Fabrication Enterprises (070577218)

Establishment
Name	Address	ID/FEI	Business Operations
Fabrication Enterprises		070577218	relabel

Establishment
Name	Address	ID/FEI	Business Operations
pure source		969241041	manufacture