FDA.reportPublic FDA data

Point Relief Cold Spot Pain Relieving Gel

Manufacturer
Fabrication Enterprises
Effective date
2024-01-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:56

Label at a glance#

ProductPoint Relief Cold Spot Pain Relieving
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of the 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 fimes per day.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

menthol - USP 12%

Purpose:

OTC - PURPOSE SECTION

external analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes

Do not apply

OTC - DO NOT USE SECTION

  • 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

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 fimes per day.

Other Ingredients:

INACTIVE INGREDIENT SECTION

aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, bromelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM (dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

Point Relief Cold Spot Pain Relieving Gel, 120mL (51452-035-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Point Relief cold Spot Pain Relieving Gel, 475mL (51452-035-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Point Relief cold Spot Pain Relieving Gel, 3.8L (51452-035-03)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Point Relief cold Spot Pain Relieving Gel, 420mL(Hands Free)(51452-035-04)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Point Relief cold Spot Pain Relieving Gel, 950mL (51452-035-05)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121666menthol 0.12 MG/MG Topical GelPSN4
2121666menthol 0.12 MG/MG Topical GelSCD4
2121666menthol 12 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-035-01Point Relief Cold Spot Pain Relieving120 mL in 1 BOTTLEGEL1204
51452-035-02Point Relief Cold Spot Pain Relieving475 mL in 1 BOTTLEGEL4754
51452-035-03Point Relief Cold Spot Pain Relieving3800 mL in 1 JUGGEL38004
51452-035-04Point Relief Cold Spot Pain Relieving420 mL in 1 TUBEGEL4204
51452-035-05Point Relief Cold Spot Pain Relieving950 mL in 1 BOTTLEGEL9504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-035POINT RELIEF COLD SPOT PAIN RELIEVING (MENTHOL) GEL [FABRICATION ENTERPRISES]4Current NDC, Legacy NDC, 5 package rows20240126_ad5d6f04-15e6-4548-95c2-32271c186bc1.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-03551452-035-01, 51452-035-02, 51452-035-03, 51452-035-04, 51452-035-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BROMELAINSU182GP2CF3IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PEPPERMINT OILAV092KU4JHIACT
METHYL SALICYLATELAV5U5022YIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML · Source PDF

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 Enterprisesad5d6f04-15e6-4548-95c2-32271c186bc12024-01-25WarningsExact identifier
ndc (package): 51452-035-05
ndc (package): 51452-035-02
ndc (package): 51452-035-04
ndc (package): 51452-035-01
ndc (package): 51452-035-03
ndc (product): 51452-035
ndc11 (package): 51452003505
ndc11 (package): 51452003501
ndc11 (package): 51452003504
ndc11 (package): 51452003502
ndc11 (package): 51452003503
spl id: 0fc4ec9e-6c21-5a8c-e063-6394a90a11ef
spl set id: ad5d6f04-15e6-4548-95c2-32271c186bc1

Reported adverse events (FAERS/openFDA)#

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