POINT RELIEF COLD SPOT PAIN RELIEVING- menthol spray

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, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

menthol - USP 10%

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, chondroitin sulfate, citric acid, eucalyptus globulus oil, glucosamine sulfate, ilex paraguariensis leaf (yerba mate) extract, isopropyl alcohol, mentha piperita (peppermint) oil, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B

Point Relief cold Spot Pain Relieving spray, 120mL (

51452-038-01)

Point Relief cold Spot Pain Relieving Spray, 475mL (

51452-038-02)

INGREDIENTS AND APPEARANCE

POINT RELIEF COLD SPOT PAIN RELIEVING 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-038-01	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/2019
2	NDC: 51452-038-02	475 mL in 1 BOTTLE, SPRAY; 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)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(51452-038)