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PROPOLIS 50g

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.08g in 50g, SODIUM FLUORIDE 0.05g in 50g
Labeler: ATOMY CO., LTD.
NDC Code: 52257-1208

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.

Drug Facts

Active ingredients: SODIUM MONOFLUOROPHOSPHATE 0.16%, SODIUM FLUORIDE 0.1%

Inactive ingredients:
Silicon Dioxide, Tetrasodium Pyrophosphate, Triclosan, D-Sorbitol Solution, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Silicon Dioxide Hydrated, Xylitol, Saccharin Sodium hydrated, Sodium Lauryl Sulfate, Green tea extracts, Propolis extracts, Orange Oil, L-Menthol, Mint Flavor, Citrus Perfumes, Purified water

Purpose: Anticaries

Warnings:
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children:
Keep out of reach of children under 6 years of age.

Indication and usage:
1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.
2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
3) Children under 2 years: Consult a dentist or doctor.

Dosage and administration:
1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.
2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
3) Children under 2 years: Consult a dentist or doctor.

PROPOLIS  50G
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1208
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (MONOFLUOROPHOSPHATE ION) SODIUM MONOFLUOROPHOSPHATE0.08 g  in 50 g
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.05 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
SODIUM PYROPHOSPHATE 
TRICLOSAN 
POLYETHYLENE GLYCOL 1500 
CARBOXYMETHYLCELLULOSE SODIUM 
XYLITOL 
SODIUM LAURYL SULFATE 
GREEN TEA LEAF 
PROPOLIS WAX 
ORANGE OIL 
LEVOMENTHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:52257-1208-150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/25/2010
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIOperations
ATOMY CO., LTD.631154601relabel
Establishment
NameAddressID/FEIOperations
KOLMAR KOREA CO., LTD.687846360manufacture

Revised: 05/2012
 
ATOMY CO., LTD.

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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