Antigingivitis/antiplaque Mouthwash
FDA Label NDC 76162-953

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Antigingivitis/antiplaque (NDC 76162-953). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding tamper evident statement, claims & disclaimer, active ingredient, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 organisims commonly associated with bad breath in as little as 15 seconds.

Active Ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product

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.

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

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.topcarebrands.com

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

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 (1.5 QT) 33.8 FL OZ

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.