FDA.reportPublic FDA data

Colgate Sensitive Pro Relief

Manufacturer
Mission Hills S.A de C.V
Effective date
2019-08-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:06:35

Label at a glance#

ProductColgate Sensitive Pro Relief
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure9 sections

Indications and uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact helps protect against cavities

Dosage and administration

adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years consult a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium fluoride 0.24% (0.14% w/v fluoride ion)Anticavity

Uses

INDICATIONS & USAGE SECTION

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

OTC - STOP USE SECTION

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 yearsconsult a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, glycerin, sorbitol, PEG-12, PVM/MA copolymer, sodium lauryl sulfate, flavor, poloxamer 407, trisodium phosphate, sodium hydroxide, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Fluoride Toothpaste for Sensitive Teeth

24/7
Protection*

Sensitive Pro-Relief™

CLINICALLY PROVEN sensitivity relief

NET WT 4.0 OZ (113 g)

Fresh Mint

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0Z2
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W72
FLUORIDE IONACTIVE MOIETYQ80VPU408O2
NITRATE IONACTIVE MOIETYT93E9Y28442
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)INACTIVE INGREDIENT389H2R62BD2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P92
PHOSPHATE IONINACTIVE INGREDIENTNK08V8K8HR2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M22
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N92
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
SORBITOLINACTIVE INGREDIENT506T60A25R2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-54965954-549-69

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
POTASSIUM NITRATERU45X2JN0ZACTIB
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)389H2R62BDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLOXAMER 407TUF2IVW3M2IACT
PHOSPHATE IONNK08V8K8HRIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 9 · 507 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE / DENTAL249 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, DELAYED RELEASE / ORAL4.2 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRALESIONAL15 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / SUBCUTANEOUSNAExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / PERIODONTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 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
8d158b50-0426-4956-a9be-24e405c0c261f6d2051c-c4ad-4c56-8d4e-31331bc328e72019-08-30WarningsExact identifier
spl id: 8d158b50-0426-4956-a9be-24e405c0c261
spl set id: f6d2051c-c4ad-4c56-8d4e-31331bc328e7

Reported adverse events (FAERS/openFDA)#

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