Top Care 971.001/971ab

Top Care 971.001/971ab
SPL v15
SPL
SPL Set ID a9b8b2fe-0a60-4f65-b6f6-aae8509c919f
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 Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol Sodium Phosphate, Dibasic, Anhydrous Sucralose Spearmint Oil Peppermint Oil Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-19

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity 

Adverse Reactions

DISTRIBUTED BY TOPCO ASOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1024 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 ASOCIATES LLC, ITASCA, IL 60143 ©TOPCO VIJA1024 QUESTIONS? 1-888-423-0139  [email protected]  www.topcarebrand.com 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

Warning

for this product

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL of rinse between your teeth for 1 miute 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 Kenvue, Inc., distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Active Ingredient

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

Other Information
  • store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Display Panel

COMPARE TO LISTERINE ®TOTAL CARE ZERO ALCOHOL ANTICAVITY MOUTHWASH*

Top Care ®

everyday

ALCOHOL FREE • FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

6 Benefits

  • Alcohol free
  • Helps prevent cavities
  • Strengthens teeth
  • Restores enamel
  • Kills bad breath germs
  • Cleans entire mouth**

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

IMPORTANT: Read direction 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

Adverse Reactions Section

DISTRIBUTED BY TOPCO ASOCIATES LLC, ITASCA, IL 60143

©TOPCO VIJA1024 QUESTIONS? 1-888-423-0139 

[email protected]  www.topcarebrand.com

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

QUALITY GUARANTEED

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 

Warning

for this product

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL of rinse between your teeth for 1 miute 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 Kenvue, Inc., distributor of Listerine ®Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Active Ingredient

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

Other Information (Other information)
  • store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Display Panel (principal display panel)

COMPARE TO LISTERINE ®TOTAL CARE ZERO ALCOHOL ANTICAVITY MOUTHWASH*

Top Care ®

everyday

ALCOHOL FREE • FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

6 Benefits

  • Alcohol free
  • Helps prevent cavities
  • Strengthens teeth
  • Restores enamel
  • Kills bad breath germs
  • Cleans entire mouth**

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

IMPORTANT: Read direction 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

Adverse Reactions Section (Adverse reactions section)

DISTRIBUTED BY TOPCO ASOCIATES LLC, ITASCA, IL 60143

©TOPCO VIJA1024 QUESTIONS? 1-888-423-0139 

[email protected]  www.topcarebrand.com

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

QUALITY GUARANTEED

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


Raw Label Data

All Sections (JSON)