Label: 2080 K HERBAL MINT- sodium fluoride paste

  • 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 January 10, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Fluoride 0.22% (0.1% w/v fluoride)

  • PURPOSE

    Purpose: anticavity

  • WARNINGS

    Do not use this product for purposes other than those described on the label.  In case of eye contact, rinse off immediately with water.  If irritation persists, seek medical help.

  • KEEP OUT OF REACH OF CHILDREN

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

  • STOP USE

    Stop using this product and consult your dentist if irritation to gums, teeth, or oral mucosa occurs

  • INDICATIONS & USAGE

    Do not swallow.  Rinse mouth with water after brushing.

    Children under 6 years:

        - To minimize swallowing, use a pea-sized amount.  Supervise brushing until good habits are established.

        - If swallowed more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    This toothpaste contains 1,000 ppm fluoride

  • INACTIVE INGREDIENT

    Inactive Ingredients: Liquid Sorbitor, Water, Silicon Dioxide, Polyethylene Glycol 1500, Sodium Lauryl Sulfate Flavor, Sodium Chloride, Sodium Carboxymethylcellulose, Saccharin Sodium Hydrate, Phosphoric Acid, Panthenol, Ginkgo Biloba Leaf Extract, Erythritol, Yellow#203, Blue#1

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    2080 K HERBAL MINT 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-0006
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.12 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R) 72 g  in 120 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 3.12 g  in 120 g
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.6 g  in 120 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.156 g  in 120 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.12 g  in 120 g
    PHOSPHORIC ACID (UNII: E4GA8884NN) 22.8 g  in 120 g
    WATER (UNII: 059QF0KO0R) 12.07 g  in 120 g
    PANTHENOL (UNII: WV9CM0O67Z) 0.6 g  in 120 g
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) 0.006 g  in 120 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00156 g  in 120 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GINKGO (UNII: 19FUJ2C58T)  
    ERYTHRITOL (UNII: RA96B954X6)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67225-0006-11 in 1 PACKAGE07/07/2016
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/07/2016
    Labeler - Aekyung Industrial Co., Ltd. (687995647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aekyung Ind. Co., Ltd._Chungyang Factory690511126manufacture(67225-0006)
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