28TAK GUM CARE TOOTH- calcium carbonate, anhydrous dibasic calcium phosphate, alcloxa, aminocaproic acid paste, dentifrice 
ELMEDITEC CO.,LTD

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 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

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)

Revised: 7/2018
Document Id: b170f130-1baa-4c37-8706-c901719c9ee3
Set id: dcb4813b-abe1-408f-8fe0-0ba1887071e1
Version: 1
Effective Time: 20180717
 
ELMEDITEC CO.,LTD