Label: TANNERS TASTY OOH LA LA ORANGE- sodium fluoride paste, dentifrice

  • NDC Code(s): 11527-045-42
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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

View All Sections
  • Drug Facts:

  • Active Ingredient:

    Sodium fluoride - 0.243%

  • PURPOSE

    Anticavity toothpaste

  • Uses:

    • Aids in the prevention of dental decay
  • Warnings:

    • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions:

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

    Inactive Ingredients: Sorbitol, Purified Water, Hydrated Silica, Xylitol, Glycerin, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Titanium Dioxide, Disodium Phosphate, Sucralose

  • Principal Panel 4.2 OZ Tube

    Tanner Tasty Paste                     NDC 11527-045-42

    0.243% Sodium Fluoride Toothpaste

    Ooh La La Orange 

    NET WT. 4.2 oz (119g)

    Principal Panel 4.2 OZ Tube

  • INGREDIENTS AND APPEARANCE
    TANNERS TASTY OOH LA LA ORANGE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-045
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-045-42119 g in 1 TUBE; Type 0: Not a Combination Product03/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/25/2021
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-045)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!