MULTI-ACTION ANTISEPTIC- cetylpyridinium chloride rinse

Multi-Action Antiseptic by

Drug Labeling and Warnings

Multi-Action Antiseptic by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

For better oral hygiene

and fresher breath

active ingredients

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

Directions

• adults ad 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 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, sucralose, benzoic acid, blue 1

disclaimer

*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.

Adverse reactions

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

299.005/299AL

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF CREST PRO-HEALTH

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ASSURED

FRESH MINT

ORAL 

HEALTH

RINSE

MULTI-ACTION ALCOHOL-FREE ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

Kills Germs That Cause Bad Breath, Plaque and the Gum Disease Gingivitis

Alcohol Free,

Freshens Breath

16.9 FL OZ (500 mL)

INGREDIENTS AND APPEARANCE

MULTI-ACTION ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0299
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: 33992-0299-7	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/09/2017

Labeler - Greenbrier International, Inc (610322518)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(33992-0299)