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SIRINMEDI ONE

Medically reviewed on March 1, 2018

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1460mg in 200g
Labeler: Sungwon Pharmaceutical Co., Ltd.
NDC Code: 76058-100

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   0.73%


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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SIRINMEDI ONE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-100
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE1460 mg  in 200 g
Inactive Ingredients
Ingredient NameStrength
Colloidal silicon Dioxide 
TRIBASIC CALCIUM PHOSPHATE 
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) 
Xylitol 
LEVOMENTHOL 
Sodium Lauryl Sulfate 
Water 
GLYCERIN 
SORBITOL 
CARBOXYMETHYLCELLULOSE SODIUM 
C12-20 ALKYL GLUCOSIDE 
POLYETHYLENE GLYCOL 4000 
Peppermint oil 
LICORICE 
GRAPEFRUIT 
PERILLA FRUTESCENS LEAF 
Packaging
#Item CodePackage Description
1NDC:76058-100-021 TUBE (TUBE) in 1 CARTON
1NDC:76058-100-01200 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)

 
Sungwon Pharmaceutical Co., Ltd.

Further information

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

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