K-MOM Baby Tooth: Package Insert and Label Information

K-MOM BABY TOOTH- poloxamer 407 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.

Poloxamer 407, Simethicone

For dental care

Keep out of reach of children

Use as small amount as a grain of rice.

Keep away from infants.

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

For dental use only

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLOXAMER 407 (POLOXAMER 407) POLOXAMER 407 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
XYLITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73429-0002-1 30 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 (73429-0002)
Establishment
Name Address ID/FEI Operations
MOTHER-K CO.,LTD 689540220 label (73429-0002)

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

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