Top Care 163.005/163ag

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoric Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-12-30

Medication Information

Purpose

Anticavity

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warnings

for this product

Directions

Adults and children under 12 years of age and older:

•use twice daily 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 anything 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 12 years of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ^®Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

TOPCO VIJA0219 QUESTIONS? 1-888-423-0139 [email protected]

TOPCO VIJA1024 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

DSP-TN-21091

DSP-MO-20087

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

QUALITY GUARANTEED

Active Ingredient

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

Other Information

•store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel

COMPARE TO LISTERINE ^®TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH*

TopCare _®

everyday

FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

EUCALYPTUS MINT

6 Benefits

Helps prevent cavities
Strengthens teeth
Restores enamel
Kills bad breath germs
Freshens breath
Cleans entire mouth**

**This product is not intended to replace brushing or flossing

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

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 under 12 years of age and older:

•use twice daily 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 anything 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 12 years of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ^®Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

TOPCO VIJA0219 QUESTIONS? 1-888-423-0139 [email protected]

TOPCO VIJA1024 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

DSP-TN-21091

DSP-MO-20087

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

QUALITY GUARANTEED

Active Ingredient (Active ingredient)

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

Other Information (Other information)

•store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO LISTERINE ^®TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH*

TopCare _®

everyday

FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

EUCALYPTUS MINT

6 Benefits

Helps prevent cavities
Strengthens teeth
Restores enamel
Kills bad breath germs
Freshens breath
Cleans entire mouth**

**This product is not intended to replace brushing or flossing

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

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

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Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "for this product", "Directions": "Adults and children under 12 years of age and older: •use twice daily 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 anything 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 12 years of age: consult a dentist or doctor", "Disclaimer": "*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Fresh Mint Anticavity Mouthwash.", "ADVERSE REACTION": "DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 TOPCO VIJA0219 QUESTIONS? 1-888-423-0139 topcare@topco.com TOPCO VIJA1024 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com DSP-TN-21091 DSP-MO-20087 Scan her for more information or call 1-888-423-0139 QUALITY GUARANTEED", "Active ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other information": "•store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F) •cold weather may temporarily cloud this product", "Inactive ingredients": "water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1", "PRINCIPAL DISPLAY PANEL": "COMPARE TO LISTERINE ® TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH* TopCare ® everyday FLUORIDE Anticavity Mouthwash SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION EUCALYPTUS MINT 6 Benefits Helps prevent cavities Strengthens teeth Restores enamel Kills bad breath germs Freshens breath Cleans entire mouth** **This product is not intended to replace brushing or flossing IMPORTANT: Read directions for proper use. 33.8 FL OZ (1 QT 1.8 FL OZ) 1 L", "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information