Antiseptic Rinse
FDA Label NDC 11344-299

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Antiseptic (NDC 11344-299). 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 active ingredient, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Cetylpyridinium chloride 0.07%

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 gun 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, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Disclaimer

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

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health® Multi-Protection Alcohol Free Rinse Refreshing Clean Mint.

Claims

**killed at least 99% of organisms commonly associated with gingivitis in as little as 15 seconds.

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse Reactions

Distributed by:

Consumer Product Partners, LLC 

St. Louis, MO 63114

1-888-593-0593

Principal Display Panel

Swan ®

COMPARE TO Crest ® Pro Health ®*

$1.25

MULTI-ACTION MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

ZESTY MINT

  • kills 99% of germs for a healther mouth**
  • Helps fight gingivitis 
  • Freshens breath
  • Alcohol free

    • 500 mL (1.05 PT) 16.9 FL OZ

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.