DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DR. ALTHEA]

DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DR. ALTHEA]
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NDC 70905-0017-1
Set ID 67fac30f-f27a-a186-e053-2a91aa0a69d7
Category HUMAN OTC DRUG LABEL
Packager Dr. Althea
Generic Name
Product Class
Product Number
Application Number PART355
  • ACTIVE INGREDIENT

    SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

  • PURPOSE

    Aids in the prevention of dental cavities.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    How to use:

    1) Squeeze toothpaste on to toothbrush.
    2) Brush thoroughly at least twice a day.
    3) Brush for 3+ minutes.
    4) Rinse out thoroughly with water.

    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 under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

    ■ Supervise children as necessary until capable of using without supervision.

    ■ Children under 2 years of age: Consult a dentist or doctor.

  • WARNINGS

    Cautions:
    1) If following symptoms occur after product use, stop using immediately: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

    ■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    SILVER, HYDRATED SILICA, CELLULOSE GUM, SORBITIOL, GLYCERIN, PEG-32, XYLITOL, MENTHOL, WATER, ETC.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0017
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70905-0017-1120 g in 1 TUBE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/01/2018
    Labeler - Dr. Althea (689694436)
    Registrant - Dr. Althea (689694436)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kumho Dental Pharm Co Ltd631133766manufacture(70905-0017)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Althea689694436label(70905-0017)

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