Cold Spot

Manufacturer: Fabrication Enterprises, inc. | Pure Source
Effective date: 2011-10-14
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:29:51

Label at a glance#

ProductCold Spot Point Relief

Active ingredientMenthol

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

menthol - usp 12%

INACTIVE INGREDIENT SECTION

aqua (deionized water), arnica montana flower (arnica) extract, chondroitin sulfate, citric acid, eucalyptus globulus oil, glucosamine sulfate,ilex paraguariensis leaf (yerba mate) extract, isopropyl alcohol, menth piperita (pepperment) oil, MSM (dimethyl sulfone) polysorbate-20, SD-alcohol 40B, triethanolamine

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, consult physician.

WARNINGS SECTION

for external use only

avoid contact with 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. if swallowed, consult physician

do not bandage tightly

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.

DOSAGE & ADMINISTRATION SECTION

wipe onto affected area. discard wipe and clean hands after use. do not use more than four times per day.

OTC - PURPOSE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cold spot point relief wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1235986	Cold Spot Point Relief 12 % Medicated Pad	PSN	4
1191164	menthol 12 % Medicated Pad	PSN	4
1235986	menthol 120 MG/ML Medicated Pad [Cold Spot]	SBD	4
1191164	menthol 120 MG/ML Medicated Pad	SCD	4
1235986	Cold Spot 120 MG/ML Medicated Pad	SY	4
1235986	Cold Spot Point Relief 12 % Medicated Pad	SY	4
1191164	menthol 12 % Medicated Wipe	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51452-004-00	2019-11-13	C162847	48780-1	97449f38-b5f1-f6ea-e053-dbdaa90aa703	coldspot point relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51452-004-00	Cold SpotPoint Relief	8 mL in 1 PACKET	SWAB	8		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51452-004	COLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]	4	Legacy NDC, 1 package rows	20111025_22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	4
Menthol	ACTIVE MOIETY	L7T10EIP3A	4
alcohol	INACTIVE INGREDIENT	3K9958V90M	4
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	4
BOSWELLIA SERRATA RESIN OIL	INACTIVE INGREDIENT	5T1XCE6K8K	4
BROMELAINS	INACTIVE INGREDIENT	U182GP2CF3	4
Chondroitin sulfate (bovine)	INACTIVE INGREDIENT	6IC1M3OG5Z	4
Citric Acid	INACTIVE INGREDIENT	2968PHW8QP	4
Dimethyl Sulfone	INACTIVE INGREDIENT	9H4PO4Z4FT	4
Eucalyptus Globulus leaf	INACTIVE INGREDIENT	S546YLW6E6	4
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	4
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	4
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	4
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

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

Cold Spot Point Relief
MENTHOL
WATER
ARNICA MONTANA FLOWER
BOSWELLIA SERRATA RESIN OIL
BROMELAINS
alcohol
Eucalyptus Globulus leaf
ILEX PARAGUARIENSIS LEAF
Peppermint Oil
Dimethyl Sulfone
Chondroitin sulfate (bovine)
Citric Acid
Isopropyl Alcohol
polysorbate 20

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51452-004	51452-004-00

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
Menthol	L7T10EIP3A	ACTIB
WATER	059QF0KO0R	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
BOSWELLIA SERRATA RESIN OIL	5T1XCE6K8K	IACT
BROMELAINS	U182GP2CF3	IACT
alcohol	3K9958V90M	IACT
Eucalyptus Globulus leaf	S546YLW6E6	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
Peppermint Oil	AV092KU4JH	IACT
Dimethyl Sulfone	9H4PO4Z4FT	IACT
Chondroitin sulfate (bovine)	6IC1M3OG5Z	IACT
Citric Acid	2968PHW8QP	IACT
Isopropyl Alcohol	ND2M416302	IACT
polysorbate 20	7T1F30V5YH	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 205 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAMUSCULAR	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates

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
2409526b-8656-40bd-aacc-92ed34dbae76			22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d	2011-10-14	Warnings	Exact identifier spl id: 2409526b-8656-40bd-aacc-92ed34dbae76 spl set id: 22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d

Reported adverse events (FAERS/openFDA)#

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