Antigingivitis/antiplaque Mouthwash
FDA Label NDC 59450-997

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Antigingivitis/antiplaque (NDC 59450-997). 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 other, active ingredient, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Kroger

Smooth Mint

KILLS THE GERMS THAT CAUSE BAD BREATH

This may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

Crest Pro-Health is a register trademark of the Proctor & Gamble Co., Cincinnati, OH

45202. The Proctor and Gamble Co. is not affiliated with thE Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202

QUESTIONS OR COMMENTS 1-800-632-6900 WWW.KROGER.COM

Active Ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque {bacteria} 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, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, blue 1

Questions?

Call 1-800-632-6900

Principal Panel Display

COMPARE TO

CREST PRO-HEALTH GUM AND BREATH

PURIFY CPC ANTIGINGIVITIS/ANTIPLAQUE

ORAL RINSE SMOOTH MINT*

Kroger

Smooth Mint

GUM DEFENSE

ALCOHOL FREE MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

KILLS THE GERMS

THAT CAUSE BAD BREATH

CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

HELPS DEFEND AGAINST EARLY SIGNS OF GUM DISEASE

HELPS IMPROVE GUM HYGIENE

SEALED WITH PRINTED NECKBAND

FOR YOUR PROTECTION

1 L (1 QT 1.8 FL OZ)

33.8 FL OZ

Image Description (Mm1)

Image Description (Mm1)

* Please review the disclaimer below.