Cold Spot

Manufacturer: Pure Source
Effective date: 2010-08-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:26:07

Label at a glance#

ProductCold Spot Point Relief

Active ingredientMENTHOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Menthol

INACTIVE INGREDIENT SECTION

Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed consult physician

WARNINGS SECTION

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 and if swallowed consult physician, do not bandage tightly.

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Use: 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ColdSpot Point Relief Pain Relieving spray, all natural ingredients.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1236002	ColdSpot POINT RELIEF 14 % Topical Ointment	PSN	2
1235999	menthol 14 % Topical Ointment	PSN	2
1236002	menthol 0.14 MG/MG Topical Ointment [Cold Spot]	SBD	2
1235999	menthol 0.14 MG/MG Topical Ointment	SCD	2
1236002	Cold Spot 0.14 MG/MG Topical Ointment	SY	2
1236002	Cold Spot Point Relief Roll-On 14 % Topical Ointment	SY	2
1235999	menthol 14 % Topical Ointment	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65121-002-03	2019-10-29	C162847	48780-1	960f7f55-d37c-8e05-e053-dbdaa90a074a	Cold Spot Point Relief Pain relieving Roll On - 3 oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65121-002-03	Cold SpotPoint Relief	90 mL in 1 BOTTLE	OINTMENT	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65121-002	COLD SPOT POINT RELIEF (MENTHOL) OINTMENT [PURE SOURCE]	2	Legacy NDC, 1 package rows	20101013_fde00a95-7bc2-4da6-8d08-d7d673313a3c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	2
CARBOMER 1342	INACTIVE INGREDIENT	809Y72KV36	2
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	2
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	2
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	2
GLUCOSAMINE SULFATE	INACTIVE INGREDIENT	1FW7WLR731	2
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	2
peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Cold Spot Point Relief
menthol
WATER
ARNICA CORDIFOLIA FLOWER
CHONDROITIN SULFATE (BOVINE)
EUCALYPTUS GLOBULUS LEAF
GLUCOSAMINE SULFATE
ILEX PARAGUARIENSIS LEAF
CARBOMER 1342
peppermint oil
DIMETHYL SULFONE
POLYSORBATE 20
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65121-002	65121-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
WATER	059QF0KO0R	IACT
ARNICA CORDIFOLIA FLOWER	JCG1OSZ7A8	IACT
CHONDROITIN SULFATE (BOVINE)	6IC1M3OG5Z	IACT
EUCALYPTUS GLOBULUS LEAF	S546YLW6E6	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
CARBOMER 1342	809Y72KV36	IACT
peppermint oil	AV092KU4JH	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
ALCOHOL	3K9958V90M	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 2 · 114 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		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	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TRANSDERMAL		30 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	EMULSION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	FILM / BUCCAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	CAPSULE / ORAL		60 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	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	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	POWDER / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TOPICAL		150 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	LOZENGE / ORAL		12 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	TABLET / SUBLINGUAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	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	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 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	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	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
peppermint oil	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CARBOMER 1342	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	CREAM / TOPICAL		2 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SOLUTION / DENTAL	0.04 %v/v		Exact identifier — unii candidate 21 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, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / ORAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 28 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
d07db448-ed4d-4c49-bc25-23400c5d95bc			fde00a95-7bc2-4da6-8d08-d7d673313a3c	2010-08-28	Warnings	Exact identifier spl id: d07db448-ed4d-4c49-bc25-23400c5d95bc spl set id: fde00a95-7bc2-4da6-8d08-d7d673313a3c

Reported adverse events (FAERS/openFDA)#

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