Top Care 838.000/838ab

SPL v3

SPL

SPL Set ID c3f2e952-a8d5-4e9d-a5c6-09e4f2544179

Route

ORAL

Published

Effective Date 2025-07-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.2 mg)

Inactive Ingredients

Water Glycerin Sodium Benzoate Potassium Sorbate Xylitol Citric Acid Monohydrate Sucralose Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-06

Description

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

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO VIJA0624 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED

Medication Information

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO VIJA0624

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

Description

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

Use

aids in the prevention of dental cavities

Warning

For this product

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 ML mark on inside of cap); do not fill above 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 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

Disclaimer

*This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath ^®for Kids! Oral Rinse

Active Ingredient

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

Other Information

store at room temperature

Inactive Ingredients

water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate

Questions Or Comments?

1-888-423-0139

Principal Display Panel

COMPARE TO THERABREATH ^® FOR KIDS! ORAL RINSE*

TopCare _®

everyday

Kids Anticavity

Fluoride Oral Rinse

Watermelon Flavored

Helps prevent cavites & strengthens teeth
Dye, Paraben, Alcohol, and Sugar Free

IMPORTANT: read directions for proper use.

10 FL OZ (296 mL)

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warning

For this product

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 ML mark on inside of cap); do not fill above 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 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

Disclaimer

*This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath ^®for Kids! Oral Rinse

Adverse Reactions (ADVERSE REACTIONS)

DISTRIBUTED BY TOPCO ASSOCIATES LLC

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

Active Ingredient (Active ingredient)

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

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THERABREATH ^® FOR KIDS! ORAL RINSE*

TopCare _®

everyday

Kids Anticavity

Fluoride Oral Rinse

Watermelon Flavored

Helps prevent cavites & strengthens teeth
Dye, Paraben, Alcohol, and Sugar Free

IMPORTANT: read directions for proper use.

10 FL OZ (296 mL)

Tamper Evident Statement (TAMPER EVIDENT STATEMENT)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warning": "For this product", "Directions": "adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 ML mark on inside of cap); do not fill above 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 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", "Disclaimer": "*This product is not manufactured or distributed by Dr. Harold Katz, LLC., distributor of TheraBreath ® for Kids! Oral Rinse ", "ADVERSE REACTIONS": "DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO VIJA0624 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Other information": "store at room temperature", "Inactive ingredients": "water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate", "Questions or comments?": "1-888-423-0139", "PRINCIPAL DISPLAY PANEL": "COMPARE TO THERABREATH ® FOR KIDS! ORAL RINSE* TopCare ® everyday Kids Anticavity Fluoride Oral Rinse Watermelon Flavored Helps prevent cavites & strengthens teeth Dye, Paraben, Alcohol, and Sugar Free IMPORTANT: read directions for proper use. 10 FL OZ (296 mL)", "TAMPER EVIDENT STATEMENT": "SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION", "Keep out of reach of children.": "If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:26.851005 · Updated: 2026-03-14T23:13:44.961646