ANTISEPTIC- cetylpyridinium chloride rinse

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Use up + up antiseptic
mouth rinse for better oral
hygiene and fresher breath.

ACTIVE INGREDIENT

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis, Antiplaque

INDICATIONS & USAGE

Use helps control plaque that can lead to gingivitis

WARNINGS

Warnings

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, tet medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information this rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT

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

QUESTIONS

Questions? Call 1-800-910-6874

ADVERSE REACTIONS

Distributed by target Corporation
Minneapolis, MN 55403
Made in U.S.A. from US and foreign components
Shop Target.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

SAFETY SEALED WITH PRINTED
NECKBAND FOR YOUR PROTECTION
antiseptic
mouth rinse
alcohol free
with CPC
Compare to active ingredient in
Crest Pro Health Clean Mint
helps kill germs that cause bad breath,
plaque and gingivitis
Soothe + Smile
up + up
mint
flavor
50.7 FL OZ (1.5L)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-299
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 188 (UNII: LQA7B6G8JG)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-299-86	1 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/21/2008

Labeler - Target Corporation (006961700)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture