CVS ANTISEPTIC- cetylpyridinium chloride rinse

CVS Antiseptic by

Drug Labeling and Warnings

CVS Antiseptic by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, 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

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.

Directions

• adults and children 6 years + older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
• do not swallow
• children two years to under 12 years of age: supervise use
• when used after brushng, 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, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, benzoic acid, blue 1

Adverse reaction

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

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

Distributed by:  CVS Pharmacy, Inc.

Once CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

299.005/299AL

principal display panel

ALCOHOL FREE

CVS Health

Compare to the active ingredient in Crest Pro-Health Rinse*

ANTISEPTIC ORAL RINSE

Sealed with printed neckband for your protection

ANTIGINGIVITIS/ANTIPLAQUES

Kills germsHelps keep teeth feeling cleanFreshens breath No burn of alcohol

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

CVS ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-299
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: 59779-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2007
2	NDC: 59779-299-21	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/01/2007

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(59779-299)