POINT RELIEF COLD SPOT Pain Relieving Gel

Manufacturer
FABRICATION ENTERPRISES
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:59

Label at a glance#

ProductPOINT RELIEF COLD SPOT Pain Relieving
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 12%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Ingredients:

INACTIVE INGREDIENT SECTION

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 LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 3.8L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121666menthol 0.12 MG/MG Topical GelPSN1
2121666menthol 0.12 MG/MG Topical GelSCD1
2121666menthol 12 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-450-01POINT RELIEF COLD SPOT Pain Relieving3800 mL in 1 JUGGEL38001
51452-450-16POINT RELIEF COLD SPOT Pain Relieving475 mL in 1 JUGGEL4751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-450POINT RELIEF COLD SPOT PAIN RELIEVING (MENTHOL) GEL [FABRICATION ENTERPRISES]1Current NDC, 2 package rows20240226_96f1d592-6cec-412e-a5fd-cf3c4f68644f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-45051452-450-16, 51452-450-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
ndc (package): 51452-450-01
ndc (package): 51452-450-16
ndc (product): 51452-450
ndc11 (package): 51452045001
ndc11 (package): 51452045016
spl id: 10c7bc76-f8e5-858c-e063-6294a90a0c13
spl set id: 96f1d592-6cec-412e-a5fd-cf3c4f68644f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.