ANTISEPTIC- cetylpyridinium chloride rinse

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

GOODSENSE
Alcohol Free Antiseptic Oral Rinse

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that can lead 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 gun 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.

DOSAGE & ADMINISTRATION

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
• 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, methylparaben, sucralose, propylparaben, blue 1

disclaimer

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

Adverse Reactions

Geiss, Destin and Dunn, Inc

Peachtree City, Ga 30269

www.valuelabels.com

1-866-696-0957

299.003/299AK

principal display panel

Germ-X

HAND SANITIZER

ORCHID GARDEN

KILLS 99.99% OF GERMS

1.25 FL OZ (0.37 mL)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-299
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-299-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/20/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/20/1993

Labeler - Geiss, Destin and Dunn, Inc (076059836)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(50804-299)