ANTISEPTIC NIGHT RINSE- cetylpyridinium chloride mouthwash

Antiseptic Night Rinse by

Drug Labeling and Warnings

Antiseptic Night Rinse by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Oral Care
Antiseptic
Night Rinse
Alcohol Free
Use at night for a cleaner
mouth in the morning

ACTIVE INGREDIENT

Active Ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis, antiplaque

INDICATIONS & USAGE

Use helps control plaque that leads 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 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.

DOSAGE & ADMINISTRATION

Directions
adults and children 6 years and 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 ears of age: do not use

GENERAL PRECAUTIONS

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

INACTIVE INGREDIENT

Inactive ingredients water, glycerin, propylene glycol, flavor, zinc lactate,
metylparaben, sodium saccharin, sucralose, propylparaben, poloxamer 188, citric acid

SPL UNCLASSIFIED SECTION

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

ADVERSE REACTIONS

DISTRIBUTED BY:
Rite Aid
30 Hunter Lane, Camp Hill, PA 17011

PRINCIPAL DISPLAY PANEL

Sealed With Printed Neckband For Your Protection
RITE
AID
PHARMACY
Compare to the actve ingredient in
Crest Pro-Health Night Oral Rinse
Oral Care
Antiseptic
Night Rinse
antigingivitis / antiplaque
mint
alcohol free
kills germs that cause bad
breath, plaque + gingivitis
fights gingivitis
cleaner mouth
in the morning
1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC NIGHT RINSE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3724
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLOXAMER 188 (UNII: LQA7B6G8JG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3724-8	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	03/17/2009

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon (790752542)

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