Label: OMNI- stannous fluoride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Stannous fluoride 0.4% w/w (0.12% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental decay

  • Warnings

    • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
    • Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
    • This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • Directions

    • Adults and children 6 years of age and older: Use a pea-sized (.25g) dose 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 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

    • Do not freeze or expose to extreme heat.
    • Do not use if tamper evident seal on top of box is broken or removed.
  • Inactive ingredients

    ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine

  • Questions or comments?

    call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249

  • Principle Display Panel

    Mint

    NDC 48878-4061-3

    3M ESPE

    OMNI Gel™

    0.4% Stannous Fluoride

    Preventive Treatment Gel

    IMPORTANT: Read

    Directions thoroughly.

    Contents:

    NET WT. 4.3 oz (121.9 g)

    Principle Display Panel
  • INGREDIENTS AND APPEARANCE
    OMNI 
    stannous fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-4061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.969 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Glycerin (UNII: PDC6A3C0OX)  
    Trolamine (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48878-4061-31 in 1 BOX02/01/1998
    1121.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/01/1998
    Labeler - Solventum US OpCo LLC (801390852)
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