Top Care D53.000/d53aa-ab

Top Care D53.000/d53aa-ab
SPL v3
SPL
SPL Set ID 3fefe9b3-d61d-494d-bd85-5d2cf8321398
Route
ORAL
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.5 mg)
Inactive Ingredients
Water Alcohol Propylene Glycol Poloxamer 407 Sucralose Benzoic Acid Sodium Benzoate Cinnamaldehyde Fd&c Blue No. 1 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-18

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use
Questions?

Call 1-888-423-0139

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO VIJA1123   QUESTIONS? 1-888-423-0139

[email protected]    www.topcarebrand.com

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

DSP-TN-21091 DSP-MO-20087

Active Ingredient

Cetylpyridinium Chloride 0.05%

Other Information
  • this rinse is not intended to replace brushing or flossing
Claims & Disclaimer

QUALITY GUARANTEED

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 ® Intense Clean Mint Mouthwash.

**Kills at least 99% of many organisms commonly associated with bad breath in as little as 15 seconds.

Inactive Ingredients

water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

Principal Panel Display

COMPARE TO CREST ®PRO-HEALTH ®INTENSE CLEAN MINT MOUTHWASH*

TopCare ® everyday

Powerful Fresh

Antigingivitis/Antiplaque

Mouthwash

FRESH MINT

  • Kills 99% of many bad breath germs**
  • Freshens your breath
  • Helps prevent plaque and gingivitis

IMPORTANT: Read directions for proper use.

1 L (1.05 QT) 33.8 FL OZ

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use
Questions?

Call 1-888-423-0139

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO VIJA1123   QUESTIONS? 1-888-423-0139

[email protected]    www.topcarebrand.com

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

DSP-TN-21091 DSP-MO-20087

Active Ingredient

Cetylpyridinium Chloride 0.05%

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
Claims & Disclaimer

QUALITY GUARANTEED

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 ® Intense Clean Mint Mouthwash.

**Kills at least 99% of many organisms commonly associated with bad breath in as little as 15 seconds.

Inactive Ingredients (Inactive ingredients)

water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

Principal Panel Display

COMPARE TO CREST ®PRO-HEALTH ®INTENSE CLEAN MINT MOUTHWASH*

TopCare ® everyday

Powerful Fresh

Antigingivitis/Antiplaque

Mouthwash

FRESH MINT

  • Kills 99% of many bad breath germs**
  • Freshens your breath
  • Helps prevent plaque and gingivitis

IMPORTANT: Read directions for proper use.

1 L (1.05 QT) 33.8 FL OZ

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


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