DR. DADDYS KIDS TOOTH- dental type silica, sodium pyrophosphate, sodium monofluorophosphate paste, dentifrice

Dr. DADDYS Kids Tooth by

Drug Labeling and Warnings

Dr. DADDYS Kids Tooth by is a Otc medication manufactured, distributed, or labeled by TB Healthcare Co., Ltd., K.Boeun Pharmaceutical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate), Sodium Monofluorophosphate

INACTIVE INGREDIENT

D-Sorbitol Solution, Concentrated Glycerin, Xanthangum, Sodium Cocoyl Glutamate, Ascorbic Acid, Hydroxyapatite, Xylitol, Sodium Chloride, Green Tea Extract, Eucalyptus Extract, Matricaria Extract, Aloe Extract, Sage Extract, Grapefruit Seed Extract, Natural Green grape flavor, Water

PURPOSE

ANTI-CAVITY

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Put an appropriate amount on a toothbrush and brush teeth.

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.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. DADDYS KIDS TOOTH 
dental type silica, sodium pyrophosphate, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76884-0010
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	13 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	0.5 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.36 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76884-0010-1	60 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2021

Labeler - TB Healthcare Co., Ltd. (695035143)

Registrant - TB Healthcare Co., Ltd. (695035143)

Establishment
Name	Address	ID/FEI	Business Operations
TB Healthcare Co., Ltd.		695035143	label(76884-0010)

Establishment
Name	Address	ID/FEI	Business Operations
K.Boeun Pharmaceutical Co.,Ltd.		695674074	manufacture(76884-0010)