Oral-b®

Oral-b®
SPL v1
SPL
SPL Set ID d8336ad5-d1fb-4290-9433-d852405d1409
Route
DENTAL
Published
Effective Date 2010-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (500 ug)

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2005-10-15
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental cavities.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.

Section 50567-7

Do not swallow.

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

Section 50570-1

Do not use if shrinkband is broken or missing.

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.
Active Ingredient

Sodium Fluoride 0.05%

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

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

Structured Label Content

Use

Aids in the prevention of dental cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50567-7 (50567-7)

Do not swallow.

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

Section 50570-1 (50570-1)

Do not use if shrinkband is broken or missing.

Purpose

Anticavity

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.
Active Ingredient (Active ingredient)

Sodium Fluoride 0.05%

Other Information (Other information)

Store above freezing.

Inactive Ingredients (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? (Question or comments?)

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

Principal Display Panel 500ml Label (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:02.378474 · Updated: 2026-03-14T22:52:21.082332