Top Care 576.001/576ac

Top Care 576.001/576ac
SPL v5
SPL
SPL Set ID 84b30711-a7e5-4189-895a-a7989f05591c
Route
ORAL
Published
Effective Date 2025-04-23
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 Saccharin Sodium Phosphoric Acid Sodium Benzoate Sucralose Poloxamer 407 Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Propylene Glycol Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-04

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION TopCare everyday Helps strengthen enamel Helps prevent cavities Kills bad breath germs Freshen Breath

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION TopCare everyday Helps strengthen enamel Helps prevent cavities Kills bad breath germs Freshen Breath

Use

aids in the prevention of dental cavities

Claims

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION

TopCare

everyday

  • Helps strengthen enamel
  • Helps prevent cavities
  • Kills bad breath germs
  • Freshen Breath
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 bwtween 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 1-888-423-0139

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0122  QUESTIONS? 1-888-423-0139

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

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

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

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, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Principal Display Panel

COMPARE TO CREST ®PRO-HEALTH™ ADVANCED ANTICAVITY FLUORIDE MOUTHWASH*

TopCare ®

everyday

ALCOHOL FREE

Fluoride

Anticavity Mouthwash

REFRESHING MINT

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

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 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

Claims (claims)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION

TopCare

everyday

  • Helps strengthen enamel
  • Helps prevent cavities
  • Kills bad breath germs
  • Freshen Breath
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 bwtween 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 1-888-423-0139

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0122  QUESTIONS? 1-888-423-0139

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.

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

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

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, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Principal Display Panel (Principal display panel)

COMPARE TO CREST ®PRO-HEALTH™ ADVANCED ANTICAVITY FLUORIDE MOUTHWASH*

TopCare ®

everyday

ALCOHOL FREE

Fluoride

Anticavity Mouthwash

REFRESHING MINT

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

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 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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