Apatite

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1380mg in 200g
Labeler: Sungwon Pharmaceutical Co., Ltd.
NDC Code: 76058-102

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 Ingredient

SODIUM MONOFLUOROPHOSPHATE   0.69%


Purpose

Anticavity

Warning

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

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

Direction

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Brush your teeth at least twice a day preferably after each meal

Use two pea sized amount for adult and one pea sized amount for children (age 2 to 6) and brushing and rinsing mouth

Inactive Ingredient

Colloidal silicon Dioxide
Tribasic Calcium Phosphate 
Chitosan
Xylitol
L-Menthol
steviol glycoside
Sodium Lauryl Sulfate
Dionized Water
Glycerine
D-sorbitol Solution
Sodium Carboxymethylcellulose
Alkyl(8-16) glcoside
Polyethylenglycol 4000
Peppermint oil
Calendura extract
Licorice Extract
Moutan Root bark Extract
Grapefruit seed extract
Perilla herb extract
Propolis extract

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APATITE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-102
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE1380 mg  in 200 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
AMINOCAPROIC ACID 
Spearmint oil 
Xylitol 
Water 
GLYCERIN 
SORBITOL 
LEVOMENTHOL 
Sodium Lauryl Sulfate 
METHYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
POLYETHYLENE GLYCOL 4000 
Sodium Chloride 
TRIBASIC CALCIUM PHOSPHATE 
Titanium Dioxide 
EUCALYPTUS OIL 
Sodium Chloride 
Packaging
#Item CodePackage Description
1NDC:76058-102-021 TUBE (TUBE) in 1 CARTON
1NDC:76058-102-01200 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/01/2011
Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)
Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)

Revised: 03/2011
 
Sungwon Pharmaceutical 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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