ANTISEPTIC- cetylpyridinium chloride mouthwash

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Wakefern Food Corp, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

seal

Sealed with printed neckband for your protection

claims

For better oral hygiene and fresher breath

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 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 Contol Center right away.

Directions

• adults and children 6 years of age & 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 product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Rinse Multi Protection Alcohol Free Rinse - Refreshing Clean Mint

Adverse Reactions

DISTRIBUTED BY

WAKEFERN FOOD CORP

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

1-800-SHOPRITE

www.shoprite.com

299.005/299AK

principal display panel

Compare to active ingredient in Crest Pro-Health Rinse

ShopRite

Antiseptic

Oral Rinse

CPC Antigingivitis/Antiplaque

ALCOHOL FREE

• Kills germs
• Help prevent plaque
• Helps keep teeth feeling clean
• Freshen Breath
• No Burn of alcohol

ZESTY MINT

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-299
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: 41190-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/08/2011

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41190-299)