K-MOM Kids Tooth: Package Insert and Label Information

K-MOM KIDS TOOTH- silicon dioxide and sodium monofluorophosphate paste, dentifrice
MOTHER-K 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.

Silica, Sodium Monofluorosphate

For dental care

Keep out of reach of children

Brush your teeth with a suitable amount of brush

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Sorbitol, Water, Glycerin, Stevioside, Hydrated Silica, etc.

For dental use only

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K-MOM KIDS TOOTH
silica, sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73429-0001
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 2 g in 100 g
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.35 g in 100 g
Inactive Ingredients
Ingredient Name Strength
XYLITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73429-0001-1 50 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2019
Labeler — MOTHER-K CO.,LTD (689540220)
Registrant — MOTHER-K CO.,LTD (689540220)
Establishment
Name Address ID/FEI Operations
KMPHARMACEUTICAL Co.,Ltd. 688679158 manufacture (73429-0001)
Establishment
Name Address ID/FEI Operations
MOTHER-K CO.,LTD 689540220 label (73429-0001)

Revised: 11/2019 MOTHER-K CO.,LTD

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