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
Purpose

Anticavity

Description

Drug Facts

Medication Information

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.
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

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.

Active Ingredient

Sodium Fluoride 0.05%

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

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.
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

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.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05%

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