Label: BUBBLE CHEEE GOLD PLUS TOOTH- sodium fluoride, allantoin paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 7, 2020

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  • ACTIVE INGREDIENTS

    Sodium Fluoride 0.1%
    Allantoin 0.05%

  • INACTIVE INGREDIENTS

    Water, PEG-40 Hydrogenated castor oil, Sodium lauroyl sarcosinate, Xylitol, Mentha piperita(peppermint)oil, Citrus limon(lemon)Fruit oil, Methyl p-Hydroxy benzoate, Petersonii oil, Sodium saccharin

  • PURPOSE

    Antiplaque
    Prevents gingivitis and periodontitis

  • WARNINGS

    The toothpaste contains 452ppm of fluorine. Do not swallow. Rinse mouth after use. Stop use and consult a dentist or a doctor if anomalies occur in the mouth or on the gums after use. For children under 6 years use a pea-sized amount per use and supervise brushing to minimize swallowing. If more than used for brushing is swallowed by children under 6 years, consult a doctor or a dentist immediately. Keep out of reach of children under 6 years of age.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Effectively prevents cavities, gum diseases, halitosis and keeps the mouth clean and fresh after just 30 seconds of use.

  • Directions

    Pump into mouth or onto a toothbrush to gargle or brush daily.

  • Other Information

    Keep in airtight container in room temperature(1~30°C).

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BUBBLE CHEEE GOLD PLUS TOOTH 
    sodium fluoride, allantoin paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79428-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 50 mL
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.025 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79428-020-021 in 1 CARTON07/01/2020
    1NDC:79428-020-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2020
    Labeler - Nature Plus (688361245)
    Registrant - Nature Plus (688361245)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPHARMACEUTICAL Co.,Ltd.688679158manufacture(79428-020)
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