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Oral-B

Oral-B Laboratories

Oral-B®Anticavity Fluoride Rinse


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Oral-B 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

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

NATURAL
MINT
FLAVOR

16.9 oz / 500ml

Oral-B

Oral-B

Sodium Fluoride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0041-1421
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 500 ug

Product Characteristics

Color
BLUE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0041-1421-16 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2005-10-15


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