ALCOHOL FREE ANTISEPTIC- cetylpyridinium chloride mouthwash

Alcohol Free Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque {bacteria} that leads to gingivitis

Warnings

for this product

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 of 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 consult a dentist or doctor

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

SPL UNCLASSIFIED SECTION

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse – Refreshing Clean Mint

Disclaimer

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE:  If you're not satisfied, we'll happily refund your money

principal display panel

Sealed with printed neckband for your protection

Compare to Crest Pro-Health

Multi-Protection

Alcohol Free Rinse

Refreshing Clean Mint

MULTI-ACTION

ALCOHOL FREE

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE RINSE

FRESH MINT

kills germs

helps prevent plaque & gingivitis

helps keep teeth feeling clean

freshens breath

no burn of alcohol

RITE

AID

PHARMACY

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ALCOHOL FREE ANTISEPTIC 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5761
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: 11822-5761-2	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/16/2019

Labeler - Rite Aid (014578892)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(11822-5761)