Label: DR. DADDYS KIDS TOOTH- dental type silica, sodium pyrophosphate, sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 76884-0010-1
- Packager: TB Healthcare Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated October 13, 2021
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. DADDYS KIDS TOOTH
dental type silica, sodium pyrophosphate, sodium monofluorophosphate paste, dentifriceProduct 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)