Label: BIOMIN RESTORE PLUS- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 29, 2020

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  • Purpose

    Anticavity & Sensitivity Relief

  • Indications for Use

    Fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

  • Instructions for Use

    Remove foil cover from nozzle, do not use if this seal has been broken. Brush twice daily for 2 minutes, ideally first thing in the morning and last thing at night, swirl the foamy dentifrice around your mouth for 30 seconds, and spit out. Do not swallow. Avoid rinsing your mouth
    with water after brushing. Replace cap after use to keep dentifrice dry.

  • Warnings and Precautions

    Continued tooth pain or sensitivivity could indicate an inherent problem that needs professional diagnosis. If symptoms persist consult your dentist. If irritation occurs, discontinue use.

  • Keep Out of Reach of Children

    Keep Out of Reach of Children. For Adults Use Only.

  • Warning

    DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS

  • Active Ingredient

    Sodium Fluoride. (Fluoride concentration is 530μg/g by weight.)

  • Inactive Ingredients

    Glycerin, Silica, PEG 400, Cocomidapropyl Betaine, Sodium Methyl Cocoyl Taurate, Titanium Dioxide, Aroma, Carbomer, Potassium Acesulfame.

  • Dosage & Administration

    Net Wt. 3.35oz (100g)

    75ml e / 100g ℮ / 3.5oz ℮.

  • Storage & Handling

    Storage temperatures limit: up to 30°C.

    Do ot use if package is damaged.

  • Carton

    Carton Label

  • Tube Label

    Tube label

  • INGREDIENTS AND APPEARANCE
    BIOMIN RESTORE PLUS 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77055-100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.53 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) 0.0055 g  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.573 g  in 1 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 0.0055 g  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.156 g  in 1 g
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 0.18 g  in 1 g
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.0075 g  in 1 g
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) 0.004 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.01 g  in 1 g
    PEPPERMINT (UNII: V95R5KMY2B) 0.0085 g  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77055-100-011 in 1 CARTON05/01/2020
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2020
    Labeler - DRCOLLINS, INC. (022002951)
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