Label: ENAMELON- stannous fluoride paste, dentifrice

  • NDC Code(s): 48783-520-08, 48783-520-43
  • Packager: Premier Dental Products Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

If you are a consumer or patient please visit this version.

  • Active ingredient

    Stannous fluoride 0.45% (0.16% w/v fluoride ion)

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  • Purpose

    Anticavity/Sensitivity Relief/Antigingivitis

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  • Uses

    • Aids in the prevention of caries
    • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • Helps prevent gingivitis
    • Helps interfere with the harmful effects of plaque associated with gingivitis
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  • Warnings

    Keep out of the reach of children under 6 years of age.

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  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.

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  • Directions

    Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

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  • Other information

    • Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
    • Do not use if foil seal on tube is broken or missing
    • Keep tightly closed when not in use
    • Store at controlled room temperature
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  • Inactive ingredients

    Glycerin, polyethylene glycol, silica, pvm/ma copolymer, cocamidopropyl betaine, calcium sulfate, poloxamer 407, dimethicone, lauroyl-sarcosine, TiO2, flavor, acesulfame k, monosodium phosphate, sucralose

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  • Questions or comments?

    Call toll-free 1-888-670-6100 Monday-Friday 8am – 5pm EST

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  • Distributed By

    Premier® Dental Products Company, Plymouth Meeting, PA 19462

    www.premusa.com www.enamelon.com

    United States Patent Numbers : US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.

    Ultramulsion® is a registered trademark of WhiteHill Oral Technologies, Inc.

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  • PRINCIPAL DISPLAY PANEL

    STRENGTHEN YOUR SMILE!

    ACPTM Enamel Therapy

    Premier®

    Enamelon Fluoride Toothpaste

    For Anticavity, Antigingivitis & Sensitive Teeth

    Mint Breeze

    NET WT 4.3 OZ (122 g)

    ULTRAMULSION®

    NDC 48783-520-43

    premier Enamelon Fluoride Toothpaste Mint Breeze 4.3 OZ (122 g)

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  • PRINCIPAL DISPLAY PANEL

    STRENGTHEN YOUR SMILE!

    ACPTM Enamel Therapy

    Premier®

    Enamelon Fluoride Toothpaste

    For Anticavity, Antigingivitis & Sensitive Teeth

    Mint Breeze

    NET WT 0.75 OZ (21.2 g)

    ULTRAMULSION®

    NDC 48783-520-08

    premier Enamelon Fluoride Toothpaste Mint Breeze 0.75 OZ (21.2 g)

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  • INGREDIENTS AND APPEARANCE
    ENAMELON 
    stannous fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:48783-520
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.00454 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    SILICON DIOXIDE  
    CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)  
    COCAMIDOPROPYL BETAINE  
    CALCIUM SULFATE  
    POLOXAMER 407  
    DIMETHICONE  
    LAUROYL SARCOSINE  
    TITANIUM DIOXIDE  
    ACESULFAME POTASSIUM  
    SODIUM PHOSPHATE, MONOBASIC  
    SUCRALOSE  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor MINT (Mint Breeze) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48783-520-43 1 in 1 CARTON
    1 122 g in 1 TUBE
    2 NDC:48783-520-08 1 in 1 CARTON
    2 21.2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 01/01/2014
    Labeler - Premier Dental Products Company (014789663)
    Establishment
    Name Address ID/FEI Business Operations
    Unicep Packaging, LLC 790263909 manufacture(48783-520), pack(48783-520), analysis(48783-520)
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