Drug Labeling and Warnings

Drug Details

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K-MOM KIDS TOOTH- silica, 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.

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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

1

K-MOM KIDS TOOTH 
silica, sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73429-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE2 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.35 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73429-0001-150 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(73429-0001) , manufacture(73429-0001) , pack(73429-0001)

Revised: 11/2019
 
MOTHER-K CO.,LTD


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