Label: ORAL-B- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 2, 2010

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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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

    Principal Display Panel - 500ml Label
  • INGREDIENTS AND APPEARANCE
    ORAL-B   ANTICAVITY
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0041-1421
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride500 ug  in 1 mL
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0041-1421-16500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35510/15/2005
    Labeler - Oral-B Laboratories (183102243)
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