ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash 
The Kroger Co

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alcohol-Free Gum Defense Mouthwash
D00.000/D00AA

Kroger

Smooth Mint

KILLS THE GERMS THAT CAUSE BAD BREATH

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

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

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

ANTIGINGIVITIS/ANTIPLAQUE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-997
Route of AdministrationOral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) Cetylpyridinium Chloride0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
zinc lactate (UNII: 2GXR25858Y)  
benzoic acid (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
sucralose (UNII: 96K6UQ3ZD4)  
sodium benzoate (UNII: OJ245FE5EU)  
poloxamer 407 (UNII: TUF2IVW3M2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59450-997-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/22/2022
Labeler - The Kroger Co (006999528)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(59450-997)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(59450-997)

Revised: 9/2022
Document Id: 716590f8-09f3-4bb4-b67c-e1c6fb5e7076
Set id: 922bff32-7536-4a6d-b04b-0b02f14fbecc
Version: 2
Effective Time: 20220923
 
The Kroger Co