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, LLC. 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	120 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-001-32	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/24/2010	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/24/2010	02/01/2021

Labeler - Fabrication Enterprises (070577218)

Registrant - Fabrication Enterprises (070577218)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(51452-001)