ANTISEPTIC- cetylpyridinium chloride rinse

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Your Military Exchanges, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

SEALED WITH PRINTED NECK BAND FOR YOUR PROTECTION

Claims

MULTI ACTION

ANTISEPTIC

RINSE

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

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 dentis if

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, puss from the gum line, loose teeth or increaded 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

Disclaimers

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

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

SATISFACTION GUARANTEED OR YOUR MONEY BACK

Adverse reactions

Manufactured For Your Military Exchanges

By: Vi-Jon

8515 Page Avenue, St. Louis, MO 63114

299.005/299AL

principal display panel

ALCOHOL

FREE

Compare To The Active Ingredient of Crest Pro-Health Rinse

exchange

select

MULTI ACTION

ANTISEPTIC RINSE

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

Zesty Mint

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

1 L (33.8 FL OZ)

Quality Value

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-299
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: 55301-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/28/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/28/2010

Labeler - Your Military Exchanges (001695568)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55301-299)