Dr. DADDYS Kids Tooth by TB Healthcare Co., Ltd. / K.Boeun Pharmaceutical Co.,Ltd.

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]

DR. DADDYS KIDS TOOTH- dental type silica, tetrasodium pyrophosphate, sodium monofluorophosphate paste, dentifrice 
TB Healthcare Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

ANTI-CAVITY

Keep out of reach of children

Put an appropriate amount on a toothbrush and brush teeth.

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.

For dental use only

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76884-0004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.36 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76884-0004-1	60 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021	03/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2021	03/14/2022

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

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

Establishment
Name	Address	ID/FEI	Business Operations
K.Boeun Pharmaceutical Co.,Ltd.		695674074	manufacture(76884-0004)

Revised: 3/2022

Document Id: da29a2a4-57bc-7d6e-e053-2995a90a9610

34390-5

Set id: b8c13f4d-9fa3-7f82-e053-2995a90a1458

Version: 3

Effective Time: 20220314