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

Topical Analgesic

Uses:

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

Warnings:

• For external use only
• Avoid contact with the 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.

• If swallowed, consult physician
• Do not bandage tightly.

Directions:

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

Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua(Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Citric Acid, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Methylsulfonylmethane (MSM), Polysorbate-80, Propyl Paraben, Propylene Glycol, SD-Alcohol 40B, Triethanolamine.

Package Labeling: 475ml

Package Labeling: 3.8L

INGREDIENTS AND APPEARANCE

POINT RELIEF COLD SPOT PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-450
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BROMELAINS (UNII: U182GP2CF3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 51452-450-16	475 mL in 1 JUG; Type 0: Not a Combination Product	02/26/2024
2	NDC: 51452-450-01	3800 mL in 1 JUG; Type 0: Not a Combination Product	02/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/26/2024

Labeler - FABRICATION ENTERPRISES (070577218)