ANTISEPTIC- cetylpyridinium chloride rinse

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

Alcohol Free

Multi-Action

Antiseptic

Oral Rinse

Sealed with printed Neckband for your protection

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

use

helps control plaque that leads to gingivitis

Warnings

for this product only

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 yearsof 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 1-888-287-1915

claims

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

Statisfaction guaranteed

For questions or comments please call 1-888-287-1915

Adverse Reaction

Distributed by Wal-Mart Stores. INC

Bentonville AR72716

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

principal display panel

Equate

Compare to Crest

Pro-Health

Rinse

Multi-Protection

Active

Ingredient

Alcohol Free

Multi-Action

Oral Rinse

Antigingivitis/Antiplaque

2X/Day Protection

• Kills germs
• Helps prevent plaque
• Helps prevent gingivitis
• Helps keep teeth feeling clean
• Freshens breath
• No burn of alcohol

Zesty Mint

Use morning & night for beter oral hygiene

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-299
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: 49035-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/22/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/22/2008

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49035-299)