ORAL-B- sodium fluoride 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]

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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

• Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste.
• Vigorously swish 10ml (as indicated inside cap) of rinse between your teeth for 1 minute then spit out. Do not swallow.
• Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in good rinsing habits to minimize swallowing.
• Supervise children as necessary until capable of using without supervision.
• Consult a dentist or physician for use by children under 6 years of age.

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

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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

• Reduces dental cavities by
  up to 40% over brushing alone
• Alcohol-free

NATURAL
MINT
FLAVOR

16.9 oz / 500ml

INGREDIENTS AND APPEARANCE

ORAL-B   ANTICAVITY
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0041-1421
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O)	Sodium Fluoride	500 ug  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0041-1421-16	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	part355	10/15/2005

Labeler - Oral-B Laboratories (183102243)