POINT RELIEF COLD SPOT PAIN RELIEVING ROLL-ON- menthol liquid

Point Relief cold Spot Pain Relieving roll-on by

Drug Labeling and Warnings

Point Relief cold Spot Pain Relieving roll-on 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 14%

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, carbomer, chondroitin sulfate, eucalyptus globulus oil, glucosamine sulfate, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methylisothiazolinone, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B, triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

POINT RELIEF COLD SPOT PAIN RELIEVING ROLL-ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	140 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-037-06	90 mL in 1 CONTAINER; 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)