SIRINMEDI ONE- sodium monofluorophosphate paste, dentifrice
Sungwon Pharmaceutical Co., Ltd.

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.

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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 older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask 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

image description

SIRINMEDI ONE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76058-100
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1460 mg in 200 g

Ingredient Name	Strength
Inactive Ingredients
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N)
XYLITOL (UNII: VCQ006KQ1E)
LEVOMENTHOL (UNII: BZ1R15MTK7)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
PEPPERMINT OIL (UNII: AV092KU4JH)
LICORICE (UNII: 61ZBX54883)
GRAPEFRUIT (UNII: O82C39RR8C)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76058-100-02	1 in 1 CARTON	03/01/2011	03/29/2019
1	NDC:76058-100-01	200 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	03/01/2011	03/29/2019

Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)

Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)

Name	Address	ID/FEI	Business Operations
Establishment
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(76058-100)

Revised: 3/2019

Document Id: 854041f9-55da-932c-e053-2a91aa0afb38

Set id: b0006c8c-8dea-48fc-8ed0-848574cc93a6

Version: 10

Effective Time: 20190329

Sungwon Pharmaceutical Co., Ltd.