ORAL-B  ANTICAVITY- sodium fluoride liquid 
Oral-B Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Oral-B®
Anticavity Fluoride Rinse

Drug Facts

Active ingredient

Sodium Fluoride 0.05%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of the reach of children.

Do not use if shrinkband is broken or missing.

Do not swallow.

If more than amount used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Store above freezing.

Inactive ingredients

Water, Glycerin, PEG 40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate, Potassium Sorbate, Phosphoric Acid, Sodium Saccharin, FD&C Blue #1

Question or comments?

1-800-56-ORALB www.oralb.com

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®

Anticavity Fluoride Rinse

NATURAL
MINT
FLAVOR

16.9 oz / 500ml

Principal Display Panel - 500ml Label
ORAL-B   ANTICAVITY
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0041-1421
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride500 ug  in 1 mL
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0041-1421-16500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35510/15/2005
Labeler - Oral-B Laboratories (183102243)

Revised: 4/2010
Document Id: 64705480-a0f6-4765-8dc4-7ae64816d3a4
Set id: d8336ad5-d1fb-4290-9433-d852405d1409
Version: 1
Effective Time: 20100402
 
Oral-B Laboratories