ANTISEPTIC- cetylpyridinium chloride rinse

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 gun 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
• 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

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROOVE VILLAGE, IL 60077

QUESTIONS? 1-888-423-0139

topcare@topcare.com

299.005/299AK

principal display panel

Sealed With Printed Neckband For Your Protection

TopCare

ALCOHOL

FREE

Oral

Health

Rinse

ANTISEPTIC

Antigingivitis/Antiplaque

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

QUALITY

GUARANTED

COMPARE TO ACTIVE INGREDIENT

OF CREST PRO-HEALTH RINSE

33.8 FL OZ

(1 QT 1.8 FL OZ) 1 L

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-299
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: 36800-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1993
2	NDC: 36800-299-21	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/03/1993

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-299)