HEALTH- cetylpyridinium chloride mouthwash

Health by

Drug Labeling and Warnings

Health by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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/AL   

principal display panel 

SEALED WITH PRINTED

NECKBAND FOR YOUR PROTECTION

healthy accents

multi-action

alcohol free

antiseptic

oral rinse

antigingivitis/antiplaque                                                                                                                                                                                                                                                                                                      

• Kills germs
• 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)

INGREDIENTS AND APPEARANCE

HEALTH 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-942
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: 55316-942-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/03/2015

Labeler - DZA Brands LLC (090322194)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55316-942)