Label: DIVINETREE SSAK SHARK KIDS TOOTH- silicon dioxide, alcloxa paste, dentifrice

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

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Drug Label Information

Updated December 4, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient: Silica 13.0%, Alcloxa 0.16%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Glycerin, Sorbitol, Cellulose Gum, Xylitol, Ascorbic Acid, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Salvia Officinalis (Sage) Leaf Extract, Calcium Glycerophosphate, Milk, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Calendula Officinalis Flower Extract, Streptococcus Thermophilus Ferment, Chamomilla Recutita (Matricaria) Flower Extract, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Flavor, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water

  • PURPOSE

    Purpose: Anticavities, Anticarries

  • WARNINGS

    Warnings:

    Keep out of the reach of children under 6 years of age.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:
    Brightens and Strengthens teeth
    Leaves the mouth clean and fresh
    Protects against gingivitis and paradentitis
    Protects against gum disease
    Removes Plaque

  • Directions

    Directions:
    Recommended for ages 3years and older
    Apply a peas size amount on toothbrush and brush teeth thoroughly. Use at least twice a day preferably after each meal or as directed by a dentist or physician.
    Children should be supervised to minimize swallowing.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DIVINETREE SSAK SHARK KIDS TOOTH 
    silicon dioxide, alcloxa paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73494-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6.50 g  in 50 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.08 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73494-010-021 in 1 CARTON11/01/2019
    1NDC:73494-010-0150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2019
    Labeler - K.biocos (695640141)
    Registrant - K.biocos (695640141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Life Science Co.,ltd694914835manufacture(73494-010)
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