OTC Medication Information: K-MOM Kids Tooth

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

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