ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

Antigingivitis/Antiplaque by

Drug Labeling and Warnings

Antigingivitis/Antiplaque by is a Otc medication manufactured, distributed, or labeled by The Kroger Co, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ANTIGINGIVITIS/ANTIPLAQUE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59450-997
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59450-997-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/22/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/22/2022

Labeler - The Kroger Co (006999528)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(59450-997)