Label: ENAMELON PREVENTIVE TREATMENT- stannous fluoride gel

  • NDC Code(s): 48783-500-40
  • Packager: Premier Dental Products Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 30, 2019

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

  • Active ingredient

    Stannous fluoride 0.40% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity/Sensitivity Relief/Antigingivitis

  • Uses

    • Aids in the prevention of cavities
    • 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
  • Warnings

    Keep out of the reach of children.

  • 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.

  • Directions

    Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

  • Other information

    This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. 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 is broken or missing
    • Keep tightly closed when not in use
    • Store at controlled room temperature
  • Inactive ingredients

    Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, sucralose

  • Questions or comments?

    Call toll-free 1-888-670-6100
    Monday-Thursday 8am-5pm EST, Friday 8am-4pm EST

  • SPL UNCLASSIFIED SECTION

    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.

    Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive Teeth

    • Relieves the discomfort of dry mouth tissues
    • Non-irritating to patients with dry mouth
    • Optimized with calcium and phosphate ions
    • No Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes

    ​Distributed by:

    Premier® Dental Products Company, Plymouth Meeting, PA 19462

    www.premusa.com Part # 9007285 www.enamelon.com

    NDC 48783-500-40 021665 Rev4 SP

  • PRINCIPAL DISPLAY PANEL

    STRENGTHEN YOUR SMILE!

    ACPTM Enamel Therapy

    Premier®

    Enamelon®

    Preventive Treatment Gel

    NET WT 4.0 OZ (113 g)

    SENSITIVITY & DRY MOUTH

    Clean Mint

    ULTRAMULSION®

    premier Enamelon Preventive Treatment Gel Clean Mint 4.0 OZ (113 g)

  • INGREDIENTS AND APPEARANCE
    ENAMELON PREVENTIVE TREATMENT 
    stannous fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48783-500
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00400 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAUROYL SARCOSINE (UNII: LIJ19P3L6F)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48783-500-401 in 1 CARTON01/01/2014
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2014
    Labeler - Premier Dental Products Company (014789663)