ANTISEPTIC- cetylpyridinium chloride mouthwash

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Liberty Procurement, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

COREVLAUES

Antiseptic

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

MULTI-ACTION

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

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 20mL (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

Safety Information

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

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint.

Adverse Reactions

Distributed by

Liberty Procurement, Inc.

650 Liberty Ave.

Union, NJ 07083 USA

Visit us at www.facevalues.com

299.005/299AK

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ALCOHOL

FREE

COREVALUES

Compare to Crest Pro-Health Clean Mint

Antiseptic

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

MULTI-ACTION

• Kills germs
• Helps prevent plaque
• Helps prevent gingivits
• Freshens breath
• Zesty Mint

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-299
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: 63940-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/11/2016

Labeler - Liberty Procurement, Inc (804085293)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(63940-299)