Cold Spot Point Relief Pain relieving Gel - 1 Gallon

Manufacturer
Fabrication Enterprises | Pure Source, LLC
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-02 00:26:22

Label at a glance#

ProductCold Spot Point Relief
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Menthol, methyl salicylate

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

pain relieving gel

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.

ColdSpot Point Relief Pain Relieving spray, all natural ingredients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton imagecarton image

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mentholACTIVE INGREDIENTL7T10EIP3A7
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y7
mentholACTIVE MOIETYL7T10EIP3A7
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ7
alcoholINACTIVE INGREDIENT3K9958V90M7
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A87
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5Z7
Citric AcidINACTIVE INGREDIENT2968PHW8QP7
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FT7
Eucalyptus Globulus LeafINACTIVE INGREDIENTS546YLW6E67
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR7317
Ilex Paraguariensis LeafINACTIVE INGREDIENT1Q953B4O4F7
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163027
Peppermint OilINACTIVE INGREDIENTAV092KU4JH7
polysorbate 20INACTIVE INGREDIENT7T1F30V5YH7
waterINACTIVE INGREDIENT059QF0KO0R7

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-00151452-001-28

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Peppermint OilPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
Citric AcidCITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8619af2a-49c8-0953-e053-2991aa0a01d162da9589-43e2-4ce0-91c2-e3b4134b22a52019-04-09WarningsExact identifier
spl id: 8619af2a-49c8-0953-e053-2991aa0a01d1
spl set id: 62da9589-43e2-4ce0-91c2-e3b4134b22a5

Reported adverse events (FAERS/openFDA)#

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