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Health by DZA Brands LLC

Medically reviewed on Jul 20, 2017

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.7mg in 1mL
Labeler: DZA Brands LLC
NDC Code: 55316-942

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.

Drug facts

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
  • 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 & older: 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 secnds 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

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 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

Adverse Reactions

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

299.005/299AK

Principal Display Panel

SEALED WITH PRINTED

NECKBAND FOR YOUR PROTECTION

healthy accents

multi-action

alcohol free

antiseptic

oral rinse

antigingivitis/antiplaque

  • Kills gersm
  • Helps prevent plaque
  • Helps prevent gingivitis
  • Helps keep teeth feeling clean
  • Freshens breath
  • No burn of alcohol

compare to the ingredients in Crest Pro-Health Multi-Protection

Alcohol Free Rinse-Refreshing Clean Mint

1 L (33.8 FL OZ)

HEALTH 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-942
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLOXAMER 188 
SACCHARIN SODIUM 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SUCRALOSE 
BENZOIC ACID 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:55316-942-861000 mL in 1 BOTTLE, PLASTIC
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 (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(55316-942)

 
DZA Brands LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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