Top Care D00.001/d00aa

Top Care D00.001/d00aa
SPL v3
SPL
SPL Set ID c20cbcca-1509-491b-9ec4-3d9611b31159
Route
ORAL
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.7 mg)
Inactive Ingredients
Glycerin Water Zinc Lactate Benzoic Acid Saccharin Sodium Sucralose Sodium Benzoate Poloxamer 407 Cinnamaldehyde Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-05

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
Disclaimer

QUALITY GUARANTEED

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

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® CPC Antigingivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

Questions?

Call 1-888-423-0139

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATED 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

Active Ingredient

Cetylpyridinium Chloride 0.07%

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

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

Principal display Panel

COMPARE TO CREST ® PRO-HEALTH ® ORAL RINSE GUM AND BREATH PURIFY*

TopCare ® everyday

ALCOHOL FREE

Gum Defense

Antigingivitis/Antiplaque

Oral Rinse

SMOOTH MINT

  • Helps improve gum hygiene
  • CPC antigingivitis/antiplaque oral rinse
  • kills germs that cause bad breath
  • helps defend against early signs of gum disease

IMPORTANT: Read directions for proper use.

1 L (1 QT 1.8 FL OZ) 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
Disclaimer

QUALITY GUARANTEED

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

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ® CPC Antigingivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

Questions?

Call 1-888-423-0139

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY TOPCO ASSOCIATED 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

Active Ingredient

Cetylpyridinium Chloride 0.07%

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

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

Principal display Panel (Principal Display Panel)

COMPARE TO CREST ® PRO-HEALTH ® ORAL RINSE GUM AND BREATH PURIFY*

TopCare ® everyday

ALCOHOL FREE

Gum Defense

Antigingivitis/Antiplaque

Oral Rinse

SMOOTH MINT

  • Helps improve gum hygiene
  • CPC antigingivitis/antiplaque oral rinse
  • kills germs that cause bad breath
  • helps defend against early signs of gum disease

IMPORTANT: Read directions for proper use.

1 L (1 QT 1.8 FL OZ) 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.


Advanced Ingredient Data


Raw Label Data

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