ANTISEPTIC- cetylpyridinium chloride rinse

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

claims

For Better Oral

Hygiene and Fresher Breath

• Kills Germs
• Helps Prevent Plaque
• Helps Prevent Gingivitis
• Helps Keep teeth feeling clean
• Freshens breath
• No Burn of Alcohol

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

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 spaceing 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 ingredents

 water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor Crest Pro-Health Rinse.

Adverse Reactions

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD, MATTHEWS, NC 28105 USA

Made in U.S.A. with U.S. and foreign components

Not 100% satisfied? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

299.003/299AJ

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO ACTIVE INGREDIENT IN CREST PRO-HEALTH RINSE

FAMILY

WELLNESS

100% SATISFACTION GUARANTEED

OR YOUR MONEY BACK

Multi-Action

Alcohol-Free

Oral Health

Mouth Rinse

Antigingivitis/Antiplaque

• 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)

Vivid Mint

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-299
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: 55319-299-86	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/02/2013

Labeler - Family Dollar Services (024472631)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55319-299)