K-MOM BABY TOOTH- simethicone, poloxamer 407 paste, dentifrice

K-MOM Baby Tooth by

Drug Labeling and Warnings

K-MOM Baby 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

Poloxamer 407, Simethicone

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Use as small amount as a grain of rice.

WARNINGS

Keep away from infants.

INACTIVE INGREDIENT

Sorbitol, Water, Xylitol, Stevioside, Cellulose Gum, Xanthan Gum, Potassium Sorbate, Etc.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

K-MOM BABY TOOTH 
simethicone, poloxamer 407 paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73429-0002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLOXAMER 407 (UNII: TUF2IVW3M2) (POLOXAMER 407 - UNII:TUF2IVW3M2)	POLOXAMER 407	2 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: 73429-0002-1	30 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(73429-0002)

Establishment
Name	Address	ID/FEI	Business Operations
MOTHER-K CO.,LTD		689540220	label(73429-0002)