Top Care 435.000/435aa

SPL v14

SPL

SPL Set ID c337c982-bd18-4a1a-851a-fca1551a242e

Route

ORAL

Published

Effective Date 2025-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Alcohol Hydrogen Peroxide Poloxamer 407 Saccharin Sodium Sucralose Menthol Phosphoric Acid Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-09-15

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1024 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com DSP-TN-21091 DSP-MO-20087 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 VIJA1024 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

DSP-TN-21091

DSP-MO-20087

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

QUALITY GUARANTEED

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children 6 years of age and older:

use twice a day after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) 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

Questions?

Call 1-888-423-0139

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information

store at room temperature (59º-77ºF)

Other Information

Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.

Inactive Ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel

Top Care _®

everyday

FLUORIDE

Whitening

Antivavity Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

5 days to whiter teeth
Begins working on contact
Safely whitens teeth
Kills germs that cause bad breath

IMPORTANT: Read direction for proper use.

32 FL OZ (1 QT) 946 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, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

for this product

Directions

Adults and children 6 years of age and older:

use twice a day after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) 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

Questions?

Call 1-888-423-0139

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Adverse Reactions (Adverse reactions)

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

[email protected] www.topcarebrand.com

DSP-TN-21091

DSP-MO-20087

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

QUALITY GUARANTEED

Other Information (Other information)

store at room temperature (59º-77ºF)

Other Information (other information)

Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.

Inactive Ingredients (Inactive ingredients)

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel (principal display panel)

Top Care _®

everyday

FLUORIDE

Whitening

Antivavity Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

5 days to whiter teeth
Begins working on contact
Safely whitens teeth
Kills germs that cause bad breath

IMPORTANT: Read direction for proper use.

32 FL OZ (1 QT) 946 mL

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, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "for this product", "Directions": "Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) 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", "Questions?": "Call 1-888-423-0139", "Active Ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Adverse reactions": "DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1024 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com DSP-TN-21091 DSP-MO-20087 Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED", "Other information": "store at room temperature (59º-77ºF)", "other information": "Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.", "Inactive ingredients": "water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor", "principal display panel": "Top Care ® everyday FLUORIDE Whitening Antivavity Mouthwash SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION FRESH MINT 5 days to whiter teeth Begins working on contact Safely whitens teeth Kills germs that cause bad breath IMPORTANT: Read direction for proper use. 32 FL OZ (1 QT) 946 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, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:48.414319 · Updated: 2026-03-14T23:13:44.961646