Cold Spot Point Relief Pain relieving Gel - 1 Gallon

Manufacturer: Pure Source
Effective date: 2010-08-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:26:09

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 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
65121-001-28	2019-10-29	C162847	48780-1	960f7f55-d16f-8e05-e053-dbdaa90a074a	Cold Spot Point Relief Pain relieving Gel - 1 Gallon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65121-001-28	Cold SpotPoint Relief	3.8 L in 1 BOTTLE, PUMP	GEL	3.8		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65121-001	COLD SPOT POINT RELIEF (MENTHOL) GEL [PURE SOURCE]	3	Legacy NDC, 1 package rows	20101018_21b499f3-99a1-446d-a113-d36faff66f23.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	3
Menthol	ACTIVE MOIETY	L7T10EIP3A	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	3
ARNICA CORDIFOLIA FLOWER	INACTIVE INGREDIENT	JCG1OSZ7A8	3
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	3
Citric Acid	INACTIVE INGREDIENT	2968PHW8QP	3
Dimethyl Sulfone	INACTIVE INGREDIENT	9H4PO4Z4FT	3
Eucalyptus Globulus Leaf	INACTIVE INGREDIENT	S546YLW6E6	3
Glucosamine sulfate	INACTIVE INGREDIENT	1FW7WLR731	3
Ilex Paraguariensis Leaf	INACTIVE INGREDIENT	1Q953B4O4F	3
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	3
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	3
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	3
water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Cold Spot Point Relief
menthol
water
ARNICA CORDIFOLIA FLOWER
CHONDROITIN SULFATE (BOVINE)
Citric Acid
Eucalyptus Globulus Leaf
Glucosamine sulfate
Ilex Paraguariensis Leaf
Isopropyl Alcohol
Peppermint Oil
Dimethyl Sulfone
polysorbate 20
alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65121-001	65121-001-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Citric Acid	2968PHW8QP	IACT
Eucalyptus Globulus Leaf	S546YLW6E6	IACT
Glucosamine sulfate	1FW7WLR731	IACT
Ilex Paraguariensis Leaf	1Q953B4O4F	IACT
Isopropyl Alcohol	ND2M416302	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 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	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
Isopropyl Alcohol	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / ORAL		269 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	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
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 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
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	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 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
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		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
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 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	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	GUM, CHEWING / BUCCAL		526 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		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
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SPRAY, METERED / NASAL		40 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
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 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
alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		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
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		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
alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Peppermint Oil	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 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	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Citric Acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		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
alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %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
ea738ac3-347b-4fbd-a049-1893172a18e8			21b499f3-99a1-446d-a113-d36faff66f23	2010-08-28	Warnings	Exact identifier spl id: ea738ac3-347b-4fbd-a049-1893172a18e8 spl set id: 21b499f3-99a1-446d-a113-d36faff66f23

Reported adverse events (FAERS/openFDA)#

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