Top Care 004.002/004ae

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.2 mg)

Inactive Ingredients

Benzyl Alcohol Edetate Calcium Disodium Cetylpyridinium Chloride Edetate Disodium Sodium Acid Pyrophosphate Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-04-08

Medication Information

Purpose

Anticavity rinse

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 once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliters (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 eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits ( to minimize swallowing)
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 Chattem, Inc., distributor of Act ^® Bubblegum Blowout ^®Anticavity Kids Fluoride Rinse.

Adverse Reaction

Distributed by: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJ717 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

QUALITY GUARANTEED

This Top Care product is laboratory tested to guarantee its highest quality. Your satisfaction is guaranteed.

Active Ingredient

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

Other Information

store at room temperature

Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

COMPARE TO ACT ^®BUBBLE GUM BLOWOUT ^®ANTICAVITY FLUORIDE RINSE*

TOP CARE _®

everyday™

Kids

Anticavity

Fluoride Rinse

BUBBLE GUM

FLAVOR

Helps prevent cavities
Alcohol free

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

ADA Accepted

American Dental Association

Helps prevent cavities

18 FL OZ (1 PT 2 FL OZ) 532 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 (PURPOSE)

Anticavity rinse

Warnings

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 milliters (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 eat or drink for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits ( to minimize swallowing)
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 Chattem, Inc., distributor of Act ^® Bubblegum Blowout ^®Anticavity Kids Fluoride Rinse.

Adverse Reaction (ADVERSE REACTION)

Distributed by: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJ717 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

QUALITY GUARANTEED

This Top Care product is laboratory tested to guarantee its highest quality. Your satisfaction is 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)

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (principal display panel)

COMPARE TO ACT ^®BUBBLE GUM BLOWOUT ^®ANTICAVITY FLUORIDE RINSE*

TOP CARE _®

everyday™

Kids

Anticavity

Fluoride Rinse

BUBBLE GUM

FLAVOR

Helps prevent cavities
Alcohol free

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

ADA Accepted

American Dental Association

Helps prevent cavities

18 FL OZ (1 PT 2 FL OZ) 532 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, seek professional assistance or contact a Poison Control Center immediately.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "PURPOSE": "Anticavity rinse", "Warnings": "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 milliters (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 eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits ( to minimize swallowing) 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 Chattem, Inc., distributor of Act ® Bubblegum Blowout ® Anticavity Kids Fluoride Rinse.", "ADVERSE REACTION": "Distributed by: TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJ717 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com QUALITY GUARANTEED This Top Care product is laboratory tested to guarantee its highest quality. Your satisfaction is guaranteed.", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Other information": "store at room temperature", "Inactive ingredients": "benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water", "principal display panel": "COMPARE TO ACT ® BUBBLE GUM BLOWOUT ® ANTICAVITY FLUORIDE RINSE* TOP CARE ® everyday™ Kids Anticavity Fluoride Rinse BUBBLE GUM FLAVOR Helps prevent cavities Alcohol free IMPORTANT: READ DIRECTIONS FOR PROPER USE. ADA Accepted American Dental Association Helps prevent cavities 18 FL OZ (1 PT 2 FL OZ) 532 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information