Point Relief Cold Spot Pain Relieving Gel

Manufacturer
Fabrication Enterprises
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:55

Label at a glance#

ProductPoint Relief Cold Spot Pain Relieving
Active ingredientMENTHOL
Label structure6 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label6Label6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121669Cold Spot POINT RELIEF 12 % Topical GelPSN2
2121666menthol 0.12 MG/MG Topical GelPSN2
2121669menthol 0.12 MG/MG Topical Gel [Cold Spot]SBD2
2121666menthol 0.12 MG/MG Topical GelSCD2
2121669Cold Spot 0.12 MG/MG Topical GelSY2
2121669Cold Spot 12 % Topical GelSY2
2121666menthol 12 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-036-06Point Relief Cold Spot Pain Relieving5 g in 1 PACKETGEL52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-036POINT RELIEF COLD SPOT PAIN RELIEVING (MENTHOL) GEL [FABRICATION ENTERPRISES]2Current NDC, Legacy NDC, 1 package rows20231106_391af69f-74aa-48cf-bc96-75e5c4e0e445.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
51452-03651452-036-06

Ingredients#

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

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

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 Enterprises391af69f-74aa-48cf-bc96-75e5c4e0e4452023-11-05WarningsExact identifier
ndc (package): 51452-036-06
ndc (product): 51452-036
ndc11 (package): 51452003606
spl id: 0973ce0d-48e1-5977-e063-6394a90ad88e
spl set id: 391af69f-74aa-48cf-bc96-75e5c4e0e445

Reported adverse events (FAERS/openFDA)#

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