POINT RELIEF COLD SPOT PAIN RELIEVING- menthol gel

Point Relief Cold Spot Pain Relieving by

Drug Labeling and Warnings

Point Relief Cold Spot Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

menthol - USP 12%

Purpose:

external analgesic

Uses:

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

Warnings:

• For external use only
• Avoid contact with eyes

Do not apply

• to open wounds or damaged skin
• If symptoms persist for more than sevan days, discontinue use and consult physician

Keep out of reach of children

• If swallowed, consult physician 
• Do not bandage tightly

Directions:

Apply directly to affected area. Do not use more than four fimes per day.

Other Ingredients:

aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

POINT RELIEF COLD SPOT PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-036
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BROMELAINS (UNII: U182GP2CF3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-036-06	5 g in 1 PACKET; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2019

Labeler - Fabrication Enterprises (070577218)