Label: MARVELOUS- stannous fluoride paste

  • NDC Code(s): 69179-000-01
  • Packager: Batool Pharma International, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 10, 2023

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  • Drug facts

  • Active Ingredients:

    Stannous Fluoride 0.454 % (0.14% w/v fluoride ion)

    Purpose

    Anticavity, antigingivitis Anti sensitivity toothpaste

  • Uses:

    Aid in the preventing of dental cavities 

    • Helps prevent gingivitis
    • Helps interfere toothpaste with harmful effects of plaque bacterias associated with gingivitis 
    • Helps control plaque bacteria that contribute to the development of gingivitis
  • Warnings

    Keep out of reach of children

    under 12 yrs. Of age. If swallowed, get medical help or contact a poison control center right away. 

    Ask dentist or physician 

    before use, if you have allergy or have allergic reaction to medications or ingredients in this product.

  • Directions

    Adult and children 12 yrs. of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or directed by a dentist or physician.

    -ASK A DENTIST

    • Do not swallow 
    • Children under 12 yrs. of age 
  • Other information

    Products containing stannous fluoride 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
    • This toothpaste is specially formulated to help prevent staining
  • Other ingredients:

    Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Carrageenan, Sodium Gluconate, Xanthan Gum, Zinc, Citrate, Stannous Chloride, Sodium Saccharin, Sodium Hydroxide, Sucralose, Titanium Dioxide, Tea Tree Oil (Melaleuca Alternafolia: Antibacterial, Anti Vital, Anti Fungus, Antiseptic)

  • Question(s):

    Email us at batoolpharma@gmail.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MARVELOUS 
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69179-000
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC (UNII: J41CSQ7QDS)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69179-000-011 in 1 CARTON08/01/2022
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/01/2022
    Labeler - Batool Pharma International, Inc. (079242646)
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