Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.5 mg)

Inactive Ingredients

Water Sorbitol Sodium Benzoate Poloxamer 407 Benzyl Alcohol Polysorbate 20 Propylene Glycol Saccharin Sodium Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Unspecified Form Edetate Calcium Disodium Cetylpyridinium Chloride Potassium Sorbate Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-02

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Uses

• aids in the prevention of dental cavities.

• the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

Directions

• adults and children 6 years of age and older:

• use once a day after brushing your teeth with a toothpaste.
• pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark.
• vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
• do not swallow the rinse.
• do not drink from the bottle.
• do not rinse mouth with water.
• do not eat or drink for 30 minutes after rinsing.
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
• supervise children as necessary until capable of using without supervision.

• children under 6 years of age: Consult a dentist or doctor.

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Other Information

Re-mineralizing action for strong and protected teeth*

✓
Alcohol Free**
✓
SLS Free
✓
Paraben Free
✓
Dye Free

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*when used as directed with a fluoride toothpaste

**contains no ethanol

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor.

Made in Taiwan

Other Information

• do not store above 25°C (77°F)

Questions Or Comments?

1-866-844-2797

Inactive Ingredients (clean Mint)

water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate

Inactive Ingredients (extra Fresh)

water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1

Principal Display Panel (clean Mint)

New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

CLEAN MINT

Cavity

Protection

Alcohol

Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204828

Back: 204832

Principal Display Panel (extra Fresh)

New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

EXTRA FRESH

Cavity

Protection

Alcohol

Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204830

Back: 204831

Structured Label Content

Uses

• aids in the prevention of dental cavities.

• the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

Purpose

Anticavity

Directions

• adults and children 6 years of age and older:

• use once a day after brushing your teeth with a toothpaste.
• pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark.
• vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
• do not swallow the rinse.
• do not drink from the bottle.
• do not rinse mouth with water.
• do not eat or drink for 30 minutes after rinsing.
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
• supervise children as necessary until capable of using without supervision.

• children under 6 years of age: Consult a dentist or doctor.

Active Ingredient (Active ingredient)

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Other Information

Re-mineralizing action for strong and protected teeth*

✓
Alcohol Free**
✓
SLS Free
✓
Paraben Free
✓
Dye Free

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*when used as directed with a fluoride toothpaste

**contains no ethanol

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor.

Made in Taiwan

Other Information (Other information)

• do not store above 25°C (77°F)

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Inactive Ingredients (clean Mint) (Inactive ingredients (Clean Mint))

water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate

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

water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1

Principal Display Panel (clean Mint) (Principal Display Panel (Clean Mint))

New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

CLEAN MINT

Cavity

Protection

Alcohol

Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204828

Back: 204832

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

New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

EXTRA FRESH

Cavity

Protection

Alcohol

Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204830

Back: 204831

Advanced Ingredient Data

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"", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE CALCIUM DISODIUM", "unii": "25IH6R4SGF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE CALCIUM DISODIUM", "unii": "25IH6R4SGF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• aids in the prevention of dental cavities. • the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.", "Purpose": "Anticavity", "Directions": "• adults and children 6 years of age and older: • use once a day after brushing your teeth with a toothpaste. • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. • do not swallow the rinse. • do not drink from the bottle. • do not rinse mouth with water. • do not eat or drink for 30 minutes after rinsing. • instruct children under 12 years of age in good rinsing habits (to minimize swallowing). • supervise children as necessary until capable of using without supervision. • children under 6 years of age: Consult a dentist or doctor.", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Other Information": "Re-mineralizing action for strong and protected teeth* ✓ Alcohol Free** ✓ SLS Free ✓ Paraben Free ✓ Dye Free ALWAYS FOLLOW THE LABEL Do not use if printed safety seal around cap is broken or missing. *when used as directed with a fluoride toothpaste **contains no ethanol Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Made in Taiwan", "Other information": "• do not store above 25°C (77°F)", "Questions or comments?": "1-866-844-2797", "Inactive ingredients (Clean Mint)": "water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate", "Inactive ingredients (Extra Fresh)": "water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1", "Principal Display Panel (Clean Mint)": "New SENSODYNE PRONAMEL ANTICAVITY FLUORIDE MOUTHWASH INTENSIVE ENAMEL REPAIR CLEAN MINT Cavity Protection Alcohol Free** Helps actively repair weakened enamel* IMPORTANT: Read directions for proper use 16.9 FL OZ (500 mL) Front: 204828 Back: 204832", "Principal Display Panel (Extra Fresh)": "New SENSODYNE PRONAMEL ANTICAVITY FLUORIDE MOUTHWASH INTENSIVE ENAMEL REPAIR EXTRA FRESH Cavity Protection Alcohol Free** Helps actively repair weakened enamel* IMPORTANT: Read directions for proper use 16.9 FL OZ (500 mL) Front: 204830 Back: 204831"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information