Top Care 482.002/482ac

Top Care 482.002/482ac
SPL v21
SPL
SPL Set ID ade7dcb2-b4e2-4cef-b9a7-469867ead68a
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Glycerin Cetylpyridinium Chloride Cinnamaldehyde Saccharin Sodium Phosphoric Acid Sodium Benzoate Sucralose Poloxamer 407 Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Propylene Glycol D&c Red No. 33 Fd&c Green No. 3

Identifiers & Packaging

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

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Warnings

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 (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 1-800-423-0139

Disclaimers

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ® Advanced Anticavity Fluoride Mouthwash, Enamel Care, Alcohol Free.

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC

Italsca, IL 60143

©TOPCO VIJA0724

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

QUALITY GUARANTEED

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

Active Ingredient

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

Inactive Ingredients

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Principal Display Panel

Sealed with printed neckband for your protection

Compare to Crest ®Pro-Health ®Advanced Anticavity Fluoride Mouthwash, Enamel Care, Alcohol Free*

Topcare ®

everyday

Alcohol free Fluoride Anticavity Mouthwash

Violet mint

  • Helps strengthen enamel
  • Helps prevent cavities
  • Helps keep mouth feeling clean
  • Kills bad breath germs
  • Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

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 daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 1-800-423-0139

Disclaimers

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ® Advanced Anticavity Fluoride Mouthwash, Enamel Care, Alcohol Free.

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC

Italsca, IL 60143

©TOPCO VIJA0724

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

QUALITY GUARANTEED

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

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Principal Display Panel (principal display panel)

Sealed with printed neckband for your protection

Compare to Crest ®Pro-Health ®Advanced Anticavity Fluoride Mouthwash, Enamel Care, Alcohol Free*

Topcare ®

everyday

Alcohol free Fluoride Anticavity Mouthwash

Violet mint

  • Helps strengthen enamel
  • Helps prevent cavities
  • Helps keep mouth feeling clean
  • Kills bad breath germs
  • Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

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

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