Label: 28TAK GUM CARE TOOTH- calcium carbonate, anhydrous dibasic calcium phosphate, alcloxa, aminocaproic acid paste, dentifrice

  • NDC Code(s): 72440-030-01, 72440-030-02
  • Packager: ELMEDITEC CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 17, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: CALCIUM CARBONATE 30.0%, ANHYDROUS DIBASIC CALCIUM PHOSPHATE 0.1%, ALCLOXA 0.1%, AMINOCAPROIC ACID 0.1%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    D-Sorbitol Solution, Aqua, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xantangum, L-Menthol, Peppermint Oil, Mint Flavor, Propolis Powder, Xylitol, Green Tea Extract, Eucalyptus Extract, Chamomile Extract, Sage Extract, Aloe Extract, Taraxacum officinale Extract, Olive leaf extract, Mastic Oil

  • PURPOSE

    Purpose: Anticavity

  • WARNINGS

    Warnings:

    (1) Do not swallow and rinse mouth thoroughly after use (2) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. (3) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. (4) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. (5) Keep out of the reach of children under 6 years of age.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:

    Keep your teeth white and strong. Keep your mouth clean. Refresh the inside of the mouth. To prevent tooth decay and remove bad breath. Increase esthetic effect. Removal of plaque (anti-plaque)

  • Directions

    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 physician

    Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

    Children under 2 years: Ask a dentist or physician

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    28TAK GUM CARE TOOTH 
    calcium carbonate, anhydrous dibasic calcium phosphate, alcloxa, aminocaproic acid paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72440-030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION36.0 g  in 120 g
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) ANHYDROUS DIBASIC CALCIUM PHOSPHATE0.12 g  in 120 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.12 g  in 120 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.12 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72440-030-021 in 1 CARTON07/01/2018
    1NDC:72440-030-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2018
    Labeler - ELMEDITEC CO.,LTD (694771074)
    Registrant - ELMEDITEC CO.,LTD (694771074)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELMEDITEC CO.,LTD694771074manufacture(72440-030)