MINT ALCOHOL FREE- cetylpyridinium chloride mouthwash

Mint Alcohol Free by

Drug Labeling and Warnings

Mint Alcohol Free by is a Otc medication manufactured, distributed, or labeled by WinCo Foods LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

WinCo

Foods

ANTISEPTIC

Oral Rinse

Alcohol-Free

FOR BETTER ORAL HYGIENE

AND FRESHER BREATH

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 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.

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 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 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 ITS OCCURRENCE.

Disclaimer

This product is not manufactured or distributed by PROCTER & GAMBLE, owner of the registered trademark CREST Pro-Health Refreshing Clean Mint.

Adverse Reactions Section

DISTRIBUTED BY:WINCO FOODS, LLC, BOISE, ID 83704

299.005/299AK

principal display panel

SEALED WITH PRINTED

NECKBAND FOR YOUR PROTECTION

Compare to the active ingredient in

CREST Pro-Health Refreshing Clean Mint

WinCo

FOODS

ANTISEPTIC

ORAL RINSE

ALCOHOL-FREE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills Germs

Helps Prevent Plaque & Gingivitis

Freshens Breath

No Burn of Alcohol

Fresh Mint

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

INGREDIENTS AND APPEARANCE

MINT ALCOHOL FREE 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-105
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: 67091-105-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/26/2014

Labeler - WinCo Foods LLC (056098817)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(67091-105)