ALCOHOL FREE ANTISEPTIC ORAL- cetylpyridinium chloride rinse

Alcohol Free Antiseptic Oral by

Drug Labeling and Warnings

Alcohol Free Antiseptic Oral by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Vi- Jon, Vi-Jon. 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

Warnings

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more tan 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 years of age: do not use

Other information

this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, propylene glycol, flavor, poloxamer 188, methylparaben, propylparaben, sodium saccharin, citric acid, yellow 6, green3

SPL UNCLASSIFIED SECTION

Sealed with printed neckband for your protection

TOP CARE
This TOP CARE product is laboratory tested to guarantee its highest quality.
Your total satisfaction is guaranteed.

This product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse*

DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139
topcare@topco.com

PRINCIPAL DISPLAY PANEL

ALCOHOL FREE
Antiseptic ORAL RINSE
ANTIGINGIVITIS/ANTIPLAQUE
Kills germs that cause bad breath, plaque and the gum disease gingivitis
Mint Flavor
COMPARE TO ACTIVE INGREDIENT OF CREST PRO-HEALTH RINSE*
1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ALCOHOL FREE ANTISEPTIC ORAL 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-223
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.07 mg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 188 (UNII: LQA7B6G8JG)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-223-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/15/1990

Labeler - Topco Associates LLC (006935977)

Registrant - Vi- Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-223)