DR. ZENNI CHILDRENS TOOTH- sodium monofluorophosphate paste, dentifrice

Dr. Zenni Childrens Tooth by

Drug Labeling and Warnings

Dr. Zenni Childrens Tooth by is a Otc medication manufactured, distributed, or labeled by Zeniton Co.,Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SODIUM MONOFLUOROPHOSPHATE

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

A proper amount of toothpaste is put on the toothbrush and the tooth is cleaned by brushing.

WARNINGS

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

6. The fluorine content of this toothpaste is 500ppm.

INACTIVE INGREDIENT

Silicon Dioxide
Concentrated Glycerin
D-Sorbitol Solution
Xanthangum
Sodium Cocoyl Glutamate
Xylitol
Grapefruit Seed Extract
Green Tea Extract
Calendula Extract
Chamomile Extract
Sage Extract
Aloe Extract
Eucalyptus Extract
Bit Red
Natural Raspberry Flavor
Water

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. ZENNI CHILDRENS TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73029-0002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.379 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73029-0002-1	60 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/2019

Labeler - Zeniton Co.,Ltd. (688416831)

Registrant - Zeniton Co.,Ltd. (688416831)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(73029-0002)

Establishment
Name	Address	ID/FEI	Business Operations
Zeniton Co.,Ltd.		688416831	label(73029-0002)