FDA.reportPublic FDA data

Colgate

Manufacturer
Mission Hills S.A de C.V
Effective date
2013-07-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:40:11

Label at a glance#

ProductColgate Sensitive Enamel Protect
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% (0.15% 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, sorbitol, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin, xanthan gum, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 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®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH*

Sensitive
enamelprotect

Clinically Proven
Sensitivity Relief

NET WT 4.0 OZ (113 g)

  • Helps Protect Against Acid Wear
  • Hardens Enamel
Principal Display Panel - 113 g Tube Carton
Principal Display Panel - 113 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65954-044-602025-02-19C16284748780-19d75b9d0-1327-f424-e053-dadaa90a57ceColgate ® Sensitive Enamel Protect Fluoride Toothpaste 4.0oz
65954-044-692025-02-19C16284748780-19d75b9d0-1327-f424-e053-dadaa90a57ceColgate ® Sensitive Enamel Protect Fluoride Toothpaste 4.0oz
65954-044-602020-01-31C16284748780-19d75b9d0-1327-f424-e053-dadaa90a57ceColgate ® Sensitive Enamel Protect Fluoride Toothpaste 4.0oz
65954-044-692020-01-31C16284748780-19d75b9d0-1327-f424-e053-dadaa90a57ceColgate ® Sensitive Enamel Protect Fluoride Toothpaste 4.0oz

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0Z2
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W72
FLUORIDE IONACTIVE MOIETYQ80VPU408O2
NITRATE IONACTIVE MOIETYT93E9Y28442
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P92
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N92
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8Z2
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 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-04465954-044-69, 65954-044-60

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
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
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 6 · 320 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FOR SUSPENSION / ORAL264 mgExact identifier — unii candidate
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED / ORAL50 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9SOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9INJECTION, SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ENTERAL2920 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM, SOLUBLE / BUCCAL47 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact 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
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / BUCCAL4 mgExact identifier — unii candidate
44 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
e3c89f7d-c0cf-4b7b-9761-87378444a9db0bbe502e-b75f-43a9-af00-df14c849e0792013-07-26WarningsExact identifier
spl set id: 0bbe502e-b75f-43a9-af00-df14c849e079

Reported adverse events (FAERS/openFDA)#

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