ALCOHOL FREE ANTISEPTIC- cetylpyridinium chloride mouthwash

Alcohol Free Antiseptic by

Drug Labeling and Warnings

Alcohol Free Antiseptic by is a Otc medication manufactured, distributed, or labeled by Kroger Co, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

Kroger

FROM OUR FAMILY TO YOURS

Mint

ALCOHOL-FREE

ANTISEPTIC RINSE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Active ingredient

Cetylpyrdinium 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 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, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Questions

Call 1-800-632-6900

Safety information

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

Adverse reactions section

DISTRIBUTED BY

THEKROGER CO

CINCINNATI, OH 45202

www.kroger.com

299.005/299AK/AL

Disclaimer

Crest Pro-Health Rinse is a registered trademark of The Procter & Gamble Company, Cincinnati, Ohio 45202.  The Procter & Gamble Company is not affilitated with The Kroger Co. or this product.

principal display panel

Kroger

ALCOHOL FREE

ANTISEPTIC

mouth

rinse

Antigingivitis/Antiplaque

Kills germs

Helps prevent plaque

Helps keep teeth feeling clean

Freshens breath

No burn of alcohol

mint

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

ALCOHOL FREE ANTISEPTIC 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-299
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)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/15/2009

Labeler - Kroger Co (006999528)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(30142-299)