Drug Facts

Drug Facts

SPL v13

SPL

SPL Set ID 34260c69-d829-46c0-b12a-5136ee073ba1

Route

ORAL

Published

Effective Date 2023-12-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Fluoride Ion (1.1 mg)

Inactive Ingredients

Glycerin Polyethylene Glycol 400 Hydrated Silica Sodium Tripolyphosphate, Unspecified Form Sodium Lauryl Sulfate Titanium Dioxide Silicon Dioxide Cocamidopropyl Betaine Saccharin Sodium

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-06-28

Description

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purpose

Anticavity, Antihypersensitivity

Medication Information

Purpose

Anticavity, Antihypersensitivity

Description

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Uses

aids in the prevention of dental cavities.
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Purposes

Anticavity, Antihypersensitivity

Directions

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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
children under 12 years of age:Consult a dentist or doctor.

Active Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Other Information

SENSODYNE REPAIR & PROTECT DEEP REPAIR

Sensodyne Repair & Protecthas a clinically proven ingredient. With twice daily brushing it helps to repair deep inside the tubules and relieves sensitivity to help you enjoy life without worrying about the pain of sensitive teeth.

EXPOSED DENTIN; CAUSE OF SENSITIVE TEETH

TINY HOLES

GETS DEEP INSIDE THESE HOLES

TO HELP REPAIR THESE HOLES

WHICH HELPS PROTECT FROM PAIN*

Daily use fluoride toothpaste to provide long lasting sensitivity relief, whilst also keeping your teeth and gums healthy. *

*with twice daily brushing

Trademarks are owned by or licensed to the Haleon group of companies.

Distributed by: Haleon, Warren, NJ 07059

Pat. Info www.productpats.com

†Recycling facilities for this product may not exist in your area

CARTONRECYCLE

TUBERECYCLE

CAPCHECK LOCALLY†

Other Information

products containing stannous fluoride may product surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
this product is specifically formulated to help prevent staining.
store above 30°C (86°F)

Questions Or Comments?

1-866-844-2797

Inactive Ingredients (mint)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, cocamidopropyl betaine, sodium saccharin

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.
pain/sensitivity still persists after 4 weeks of use.

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.

Principal Display Panel (mint)

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

REPAIR & PROTECT

DEEP REPAIR

NET WT 3.4 OZ (96.4 g)

62000000207021

Inactive Ingredients (whitening)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, cocamidopropyl betaine, sodium saccharin

Inactive Ingredients (extra Fresh)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, sodium saccharin, cocamidopropyl betaine

Principal Display Panel (whitening)

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

WHITENING

REPAIR & PROTECTED

DEEP REPAIR

NET WT 3.4 OZ (96.4 g)

62000000207026

Principal Display Panel (extra Fresh)

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

REPAIR & PROTECT

DEEP REPAIR

NET WT 3.4 OZ (96.4 g)

62000000207114

Structured Label Content

Uses

aids in the prevention of dental cavities.
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Purposes

Anticavity, Antihypersensitivity

Directions

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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
children under 12 years of age:Consult a dentist or doctor.

Active Ingredient (Active ingredient)

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Other Information

SENSODYNE REPAIR & PROTECT DEEP REPAIR

EXPOSED DENTIN; CAUSE OF SENSITIVE TEETH

TINY HOLES

GETS DEEP INSIDE THESE HOLES

TO HELP REPAIR THESE HOLES

WHICH HELPS PROTECT FROM PAIN*

Daily use fluoride toothpaste to provide long lasting sensitivity relief, whilst also keeping your teeth and gums healthy. *

*with twice daily brushing

Trademarks are owned by or licensed to the Haleon group of companies.

Distributed by: Haleon, Warren, NJ 07059

Pat. Info www.productpats.com

†Recycling facilities for this product may not exist in your area

CARTONRECYCLE

TUBERECYCLE

CAPCHECK LOCALLY†

Other Information (Other information)

products containing stannous fluoride may product surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
this product is specifically formulated to help prevent staining.
store above 30°C (86°F)

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Inactive Ingredients (mint) (Inactive ingredients (Mint))

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, cocamidopropyl betaine, sodium saccharin

Stop Use and Ask A Dentist If (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.
pain/sensitivity still persists after 4 weeks of use.

Keep Out of Reach of Children. (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.

Principal Display Panel (mint) (Principal Display Panel (Mint))

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

REPAIR & PROTECT

DEEP REPAIR

NET WT 3.4 OZ (96.4 g)

62000000207021

Inactive Ingredients (whitening) (Inactive ingredients (Whitening))

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, cocamidopropyl betaine, sodium saccharin

Inactive Ingredients (extra Fresh) (Inactive ingredients (Extra Fresh))

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, sodium saccharin, cocamidopropyl betaine

Principal Display Panel (whitening) (Principal Display Panel (Whitening))

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

WHITENING

REPAIR & PROTECTED

DEEP REPAIR

NET WT 3.4 OZ (96.4 g)

62000000207026

Principal Display Panel (extra Fresh) (Principal Display Panel (Extra Fresh))

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

REPAIR & PROTECT

DEEP REPAIR

NET WT 3.4 OZ (96.4 g)

62000000207114

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM", "unii": "5HK03SA80J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM", "unii": "5HK03SA80J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "aids in the prevention of dental cavities. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.", "Purposes": "Anticavity, Antihypersensitivity", "Directions": "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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age: Consult a dentist or doctor.", "Active ingredient": "Stannous fluoride 0.454% (0.15% w/v fluoride ion)", "Other Information": "SENSODYNE REPAIR & PROTECT DEEP REPAIR Sensodyne Repair & Protect has a clinically proven ingredient. With twice daily brushing it helps to repair deep inside the tubules and relieves sensitivity to help you enjoy life without worrying about the pain of sensitive teeth. EXPOSED DENTIN; CAUSE OF SENSITIVE TEETH TINY HOLES GETS DEEP INSIDE THESE HOLES TO HELP REPAIR THESE HOLES WHICH HELPS PROTECT FROM PAIN* Daily use fluoride toothpaste to provide long lasting sensitivity relief, whilst also keeping your teeth and gums healthy. * *with twice daily brushing Trademarks are owned by or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Distributed by: Haleon, Warren, NJ 07059 Pat. Info www.productpats.com †Recycling facilities for this product may not exist in your area CARTON RECYCLE TUBE RECYCLE CAP CHECK LOCALLY†", "Other information": "products containing stannous fluoride may product surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. this product is specifically formulated to help prevent staining. store above 30°C (86°F)", "Questions or comments?": "1-866-844-2797", "Inactive ingredients (Mint)": "glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, cocamidopropyl betaine, sodium saccharin", "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. pain/sensitivity still persists after 4 weeks of use.", "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.", "Principal Display Panel (Mint)": "#1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION MINT REPAIR & PROTECT DEEP REPAIR NET WT 3.4 OZ (96.4 g) 62000000207021", "Inactive ingredients (Whitening)": "glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, cocamidopropyl betaine, sodium saccharin", "Inactive ingredients (Extra Fresh)": "glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, silica, sodium saccharin, cocamidopropyl betaine", "Principal Display Panel (Whitening)": "#1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION WHITENING REPAIR & PROTECTED DEEP REPAIR NET WT 3.4 OZ (96.4 g) 62000000207026", "Principal Display Panel (Extra Fresh)": "#1 DENTIST RECOMMENDED BRAND SENSODYNE FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION EXTRA FRESH REPAIR & PROTECT DEEP REPAIR NET WT 3.4 OZ (96.4 g) 62000000207114"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:50.852505 · Updated: 2026-03-14T23:02:37.591705