DIVINETREE SSAK SHARK KIDS TOOTH- silicon dioxide, alcloxa paste, dentifrice 
K.biocos

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.

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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

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)

Revised: 12/2019
Document Id: 2e6d3fb6-bd1f-4e1a-a24e-cdb31dbb1c20
Set id: 7ef2f4c1-1592-4064-8124-bfc18154858c
Version: 1
Effective Time: 20191204
 
K.biocos