Therabreath For Kids Anti Cavity Oral Rinse

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.0005 g)

Inactive Ingredients

Water Xylitol Anhydrous Citric Acid Sodium Benzoate Glycerin Grape Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-10-01

Medication Information

Purpose

Anticavity

Description

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

Use

Aids in the prevention of dental cavities

Warnings

Keep Out Of Reach of Children.

Directions

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a

toothpaste. Vigorously swish 10 milliliters 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.

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, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

Therabreath Kids Anti Cavity Oral Rinse

Structured Label Content

Use

Aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

Keep Out Of Reach of Children.

Directions

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a

toothpaste. Vigorously swish 10 milliliters 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.

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

Water, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

Therabreath Kids Anti Cavity Oral Rinse (TheraBreath Kids Anti Cavity Oral Rinse)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GRAPE", "unii": "6X543N684K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.0005", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "Keep Out Of Reach of Children.", "Directions": "• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters 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.", "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, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate"}

Therabreath For Kids Anti Cavity Oral Rinse

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information