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MITNTY OCEAN SALT TOOTH

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.45g in 100g
Labeler: RUCIPELLOKOREA INC.
NDC Code: 71325-0002

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SODIUM MONOFLUOROPHOSPHATE

For dental care

Keep out of reach of children

Apply proper amount and brush teeth thoroughly

If more than used for brushing is accidentally swallowed, get medical help.

Sorbitol, water, etc.

For dental use only

MITNTY OCEAN SALT TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71325-0002
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.45 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL 
SORBITOL 
WATER 
HYDRATED SILICA 
Packaging
#Item CodePackage Description
1NDC:71325-0002-1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/25/2017
Labeler - RUCIPELLOKOREA INC. (694074164)
Registrant - RUCIPELLOKOREA INC. (694074164)
Establishment
NameAddressID/FEIOperations
Kumho Dental Pharm Co Ltd631133766manufacture(71325-0002)
Establishment
NameAddressID/FEIOperations
RUCIPELLOKOREA INC.694074164label(71325-0002)

Revised: 08/2017
 
RUCIPELLOKOREA INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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