Point Relief cold Spot Pain Relieving roll-on

Manufacturer: Fabrication Enterprises
Effective date: 2023-11-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:58:56

Label at a glance#

ProductPoint Relief cold Spot Pain Relieving roll-on

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 14%

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, carbomer, chondroitin sulfate, eucalyptus globulus oil, glucosamine sulfate, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methylisothiazolinone, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B, triethanolamine

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2121685	Cold Spot POINT RELIEF 14 % Topical Solution	PSN	2
2121681	menthol 140 MG/mL Topical Solution	PSN	2
2121685	menthol 140 MG/ML Topical Solution [Cold Spot]	SBD	2
2121681	menthol 140 MG/ML Topical Solution	SCD	2
2121685	Cold Spot 14 % Topical Solution	SY	2
2121685	Cold Spot 140 MG/ML Topical Solution	SY	2
2121681	menthol 14 % Topical Solution	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51452-037-06	Point Relief cold Spot Pain Relieving roll-on	90 mL in 1 CONTAINER	LIQUID	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51452-037	POINT RELIEF COLD SPOT PAIN RELIEVING ROLL-ON (MENTHOL) LIQUID [FABRICATION ENTERPRISES]	2	Current NDC, Legacy NDC, 1 package rows	20231106_3f1db0ad-aaa8-4e14-9349-45057e0fb4a6.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Point Relief cold Spot Pain Relieving roll-on
MENTHOL
WATER
ARNICA MONTANA FLOWER
INDIAN FRANKINCENSE
CARBOXYPOLYMETHYLENE
EUCALYPTUS OIL
GLUCOSAMINE SULFATE
GLYCYRRHIZA GLABRA
ILEX PARAGUARIENSIS LEAF
PEPPERMINT OIL
METHYLISOTHIAZOLINONE
DIMETHYL SULFONE
POLYSORBATE 20
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51452-037	51452-037-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
INDIAN FRANKINCENSE	4PW41QCO2M	IACT
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
TROLAMINE	9O3K93S3TK	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Point Relief cold Spot Pain Relieving roll-on	MENTHOL	Fabrication Enterprises	3f1db0ad-aaa8-4e14-9349-45057e0fb4a6	2023-11-05	Warnings	Exact identifier ndc (package): 51452-037-06 ndc (product): 51452-037 ndc11 (package): 51452003706 spl id: 0973b73d-5dde-0986-e063-6294a90a5917 spl set id: 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6

Reported adverse events (FAERS/openFDA)#

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