Oral-b
FDA Label NDC 0041-1421

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oral-b Laboratories for the product Oral-b (NDC 0041-1421). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, otc - keep out of reach of children, otc - do not use, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Fluoride 0.05%

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Do Not Use

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.

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

    Principal Display Panel (500ml Label)

    Principal Display Panel (500ml Label)

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