HEALTH- cetylpyridinium chloride mouthwash 
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antiseptic Mouthrinse
299.005/299AK-AL

Claims

Healthy

Accents

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

Keep out of reach of children

under 6 years of age & older: If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Healthy Accents

For Better Oral Hygiene and Fresher Breath

This rinse may cause temporary staining to the surface of teeth.  This is not harmful and adequate brushing may prevent it occurence.

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

DISTRIBUTED BY:DZA BRANDS, LLC

2110 Executive Drive

Salisbury, NC 28147

For product questions or concerns,

contact us at 1-866-322-2439

Please include UPC number and code from the package

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healthy accents multi-action alcohol free antiseptic oral rinse

antigingivitis/antiplaque

compare to the ingredients in Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint*

1 L (33.8 FL OZ)

image description

HEALTH 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-942
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-942-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/03/2015
Labeler - DZA Brands LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-942)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-942)

Revised: 6/2022
Document Id: 155570f2-39c9-4a3c-b433-d97c2a61fc6d
Set id: 807973cf-a60d-4259-aa45-79624d66f6f8
Version: 10
Effective Time: 20220628
 
DZA Brands LLC