MINT- cetylpyridinium chloride mouthwash

Mint by

Drug Labeling and Warnings

Mint by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

Sealed with printed neckband for your protection

ORAL HEALTH

Antiseptic

Rinse

Mint

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

claims

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, distributor of Crest Pro-Health Rinse

Adverse Reactions Section

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-SAFEWAY www.safeway.com

299.005/299AK

principle display panel

SAFEWAY

CARE

Quality Guaranteed

ORAL HEALTH

Antiseptic Rinse

Mint

Alcohol Free

Antigingivitis

Antiplaque

Comapre to the active ingredients in Crest Pro-Health Rinse

1 L

(33.8OZ) FL OZ

INGREDIENTS AND APPEARANCE

MINT 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-299
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: 21130-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/29/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/29/2009

Labeler - Safeway, Inc (009137209)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(21130-299)