ORAL-B ANTI-BACTERIAL- cetylpyridinium chloride liquid

Oral-B by

Drug Labeling and Warnings

Oral-B by is a Otc medication manufactured, distributed, or labeled by Oral-B Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Anti-bacterial

Use

To fight plaque and bad breath bacteria.

Warnings

Keep out of the reach of children.

Not for use by children under six years of age.

Children over six should be supervised when using this product.

Do not use if shrinkband is broken or missing.

Do not swallow.

Directions

Rinse twice daily, after brushing, with 1/2 a capful (15 ml) for about 30 seconds.

Other information

Store above freezing.

Inactive ingredients

Water, Glycerin, Alcohol (9.3%), Flavor, Poloxamer 407, Methylparaben, Sodium Saccharin, Propylparaben, FD&C Blue #1, and D&C Yellow #10

Question or comments?

1-800-56-ORALB
http://www.oralb.com

SPL UNCLASSIFIED SECTION

Distributed by:
Oral-B, A Division of
Procter & Gamble
Cincinnati, OH 45202

© Oral-B Laboratories

Made in Colombia

PRINCIPAL DISPLAY PANEL - 500ml Label

Oral -B®

Anti-Bacterial Rinse

• Dual action formula kills
  plaque and bad breath
  bacteria on contact

NATURAL
MINT
FLAVOR

16.9 oz / 500ml

INGREDIENTS AND APPEARANCE

ORAL-B  ANTI-BACTERIAL
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0041-1420
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	500 ug  in 1 mL

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0041-1420-16	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/15/2005

Labeler - Oral-B Laboratories (183102243)