ANTISEPTIC- cetylpyridinium chloride mouthwash

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Optional Claims

FOR BETTER ORAL HYGIENE AND FRESHER BREATH

KILLS MILLIONS OF GERMS WITHOUT THE BURN OF ALCOOL

HELPS REMOVE GERMS THAT CAUSE PLAQUE, GINGIVITIS AND BAD BREATH

Active ingredient

Active ingredient
Cetylpyridinium Chloride 0.07%

Purpose

Purpose

Antigingivitis, Antiplaque

Use

Use helps control plaque that leads to gingivitis

Warnings

Warnings

Stop use and ask a dentist if

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

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

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

Other information

• this rinse is not intended to replace brushing or flossing

Inactive ingredients

Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, methylparaben, sucralose, propylparaben, blue 1

Disclaimer

This produc tis not manufatured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse

Adverse Reaction

DISTRIBUTED BY ONPOINT, INC

2 PARAGON DRIVE

MONTVALE, NJ 07645

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTIN

LiveBetter

Alcohol-Free

Antiseptic

Oral Rinse

ZESTY MINT

Compare to Active Ingredients in

Crest Pro-Health Rinse

• ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE
• KILLS GERMS
• HELPS PREVENT PLAQUE
• HELPS PREVENT GINGIVITIS
• HELPS KEEP TEETH FEELING CLEAN
• FRESHENS BREATH
• NO BURN OF ALCOHOL

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51143-299
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 DIHYDRATE (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
sucralose (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51143-299-86	1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/27/2010

Labeler - Onpoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(51143-299)