Drug Labeling and Warnings

Drug Details

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K-MOM BABY TOOTH- simethicone, 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.

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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

1

K-MOM BABY TOOTH 
simethicone, poloxamer 407 paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73429-0002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLOXAMER 407 (UNII: TUF2IVW3M2) (POLOXAMER 407 - UNII:TUF2IVW3M2) POLOXAMER 4072 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73429-0002-130 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2019
Labeler - MOTHER-K CO.,LTD (689540220)
Registrant - MOTHER-K CO.,LTD (689540220)
Establishment
NameAddressID/FEIBusiness Operations
MOTHER-K CO.,LTD689540220label(73429-0002) , manufacture(73429-0002) , pack(73429-0002)

Revised: 11/2019
 
MOTHER-K CO.,LTD


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