Clōsys®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.05 g)

Inactive Ingredients

Water Chlorine Dioxide Sodium Phosphate, Tribasic, Dodecahydrate Anhydrous Citric Acid Peppermint Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2016-02-18 Until 2025-05-31

Medication Information

Purpose

Anticavity

Description

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

Use:

Aids in the prevention of dental cavities

Section 42229-5

Section 50565-1

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

Section 53413-1

Questions or comments? Call 1-800-643-3337

Packaging

473ml Inner Label

473 mL Carton

100 ml Label

Active Ingredient

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

Other Information:

Do not use if safety seal is broken or missing

Inactive Ingredients:

water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose

Directions: Adults and Children 6 Years of Age and Older:

Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · 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.

Structured Label Content

Use: (USE:)

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

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

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-643-3337

Purpose (PURPOSE)

Anticavity

Packaging

473ml Inner Label

473 mL Carton

100 ml Label

Active Ingredient (ACTIVE INGREDIENT)

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

Other Information: (OTHER INFORMATION:)

Do not use if safety seal is broken or missing

Inactive Ingredients: (INACTIVE INGREDIENTS:)

water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose

Directions: Adults and Children 6 Years of Age and Older: (DIRECTIONS: Adults and children 6 years of age and older:)

Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · 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.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORINE DIOXIDE", "unii": "8061YMS4RM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE", "unii": "B70850QPHR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE:": "Aids in the prevention of dental cavities", "50565-1": "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. ", "53413-1": "Questions or comments? Call 1-800-643-3337", "PURPOSE": "Anticavity", "Packaging": "473ml Inner Label 473 mL Carton 100 ml Label", "ACTIVE INGREDIENT": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "OTHER INFORMATION:": "Do not use if safety seal is broken or missing", "INACTIVE INGREDIENTS:": "water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose", "DIRECTIONS: Adults and children 6 years of age and older:": "Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information