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TROPICAL OCEAN TOOTH

Medically reviewed on Aug 25, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.4g in 100g
Labeler: RUCIPELLOKOREA INC.
NDC Code: 71325-0003

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

TROPICAL OCEAN TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71325-0003
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL 
SORBITOL 
WATER 
HYDRATED SILICA 
Packaging
#Item CodePackage Description
1NDC:71325-0003-1100 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(71325-0003)
Establishment
NameAddressID/FEIOperations
RUCIPELLOKOREA INC.694074164label(71325-0003)

 
RUCIPELLOKOREA INC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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