Label: KILL FIRETOOTHPASTE- sodium fluoride paste

  • NDC Code(s): 24765-133-01
  • Packager: Pharmacal-International. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated August 17, 2023

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  • Active ingredient

    Sodium Fluoride 0.02%

    Purpose

    • Anticavity Toothpaste

    Use

    • Aids in the prevention of dental cavities

    Directions

    • Apply appropriate amount on a toothbrush and brush teeth.

    Warnings

    • Be careful not to swallow. Rinse mouth thoroughly after use.
    • If pain occurs when using this product, stop using and consult your dentist.
    • For children under 6 years of age, use a pea size amount of toothpaste as recommended by the KFDA. Use under the guidance of a guardian.
    • If a child under 6 years old swallows a large amount, consult a physician or dentist immediately.
    • Keep out of the reach of children under 6 years old.

    Inactive ingredients

    Silica,Sorbitol, Tetrasodium Pyrophosphate, Tocopheryl Acetate,
    Xylitol, Glucosyl Stevioside, Hydrated Silica, Cellulose Gum, Sodium lauryl Sulfate, Menthol,
    Chamomilla Recutita (Matricaria) Extract, Artemisia Princeps Extract, Zingiber Officinale (Ginger) Root Extract,
    Melaleuca Alternifolia (Tea Tree) Leaf Oil, Flavor, Gardenia Red, Water

    Effect- Efficacy

    • Whitens teeth while fighting germs
    • Long-lasting freshness and clean mouth feel
    • Protects against cavities and bad breath
    • Natural brightness of your teeth shines
    • Anti plaque
    • Helps prevent plaque, gingivitis cavities and gum disease
  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    KILL FIRETOOTHPASTE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    GINGER (UNII: C5529G5JPQ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-133-01100 g in 1 TUBE; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/15/2021
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
    Registrant - Pharmacal-International. Co., Ltd. (557805060)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPHARMACEUTICAL Co.,Ltd.689850153manufacture(24765-133)
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