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

Purpose

Antigingivitis, Antiplaque

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Medication Information

Warnings

for this product

Purpose

Antigingivitis, Antiplaque

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
Other Information
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

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

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Questions?

Call 1-888-423-0139

Use

helps control plaque that leads to gingivitis

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%

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.

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

Warnings

for this product

Purpose

Antigingivitis, Antiplaque

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
Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients (Inactive ingredients)

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

Questions?

Call 1-888-423-0139

Use

helps control plaque that leads to gingivitis

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%

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.

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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