K-MOM KIDS TOOTH- silica, sodium monofluorophosphate paste, dentifrice

K-MOM Kids Tooth by

Drug Labeling and Warnings

K-MOM Kids Tooth by is a Otc medication manufactured, distributed, or labeled by MOTHER-K CO.,LTD, KMPHARMACEUTICAL Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silica, Sodium Monofluorosphate

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Brush your teeth with a suitable amount of brush

WARNINGS

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	2 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.35 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73429-0001-1	50 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2019

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	Business Operations
KMPHARMACEUTICAL Co.,Ltd.		688679158	manufacture(73429-0001)

Establishment
Name	Address	ID/FEI	Business Operations
MOTHER-K CO.,LTD		689540220	label(73429-0001)