POINT RELIEF COLD SPOT PAIN RELIEVING- menthol gel 
FABRICATION ENTERPRISES

----------

POINT RELIEF COLD SPOT Pain Relieving Gel

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:

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

Label

Package Labeling: 3.8L

Label2

POINT RELIEF COLD SPOT PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51452-450-16475 mL in 1 JUG; Type 0: Not a Combination Product02/26/2024
2NDC:51452-450-013800 mL in 1 JUG; Type 0: Not a Combination Product02/26/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/26/2024
Labeler - FABRICATION ENTERPRISES (070577218)

Revised: 2/2024
Document Id: 10c7bc76-f8e5-858c-e063-6294a90a0c13
Set id: 96f1d592-6cec-412e-a5fd-cf3c4f68644f
Version: 1
Effective Time: 20240207
 
FABRICATION ENTERPRISES