ESIRIN X- sodium monofluorophosphate paste
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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76058-107

Sodium Monofluorophosphate 0.7%

Silicon Dioxide

Tricalcium phosphate

Calcium phospahte, dibasic, dihydrate

Glycerin

Sorbitol

Polyehtylene glycol 1500

Xylitol

Stevioside

Carboxymethylcellulose sodium

methyl 3 Hydroxybenzoate

Mockdanpi Extract

Calendula officinalis flower

peppermint oil

L-menthol

Sodium lauryl sulfate

Chitosan

Grapefruit

Green tea leaf

CL 16185

Water

Keep out of Reach of Children.

Anticaries

Do not use this toothpaste except brushing teeth.

Do not leave without the cap, give too much pressure also.

Do not contain this toothpaste with unoriginal tube.

Helps protect against cavities, alleviates tooth ache

Put tooth paste until about 2 cm onto affected area and massage 1 minute. After massaging brush teeth with soft tooth brush.

image of Esirin

ESIRIN X
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76058-107
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 g in 200 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
XYLITOL (UNII: VCQ006KQ1E)
STEVIOSIDE (UNII: 0YON5MXJ9P)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
METHYL 3-HYDROXYBENZOATE (UNII: 569M9G3STJ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GRAPEFRUIT (UNII: O82C39RR8C)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
LEVOMENTHOL (UNII: BZ1R15MTK7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76058-107-02	1 in 1 CARTON	03/31/2013	03/28/2019
1	NDC:76058-107-01	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	03/31/2013	03/28/2019

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(76058-107)

Revised: 3/2019

Document Id: 8530a5a4-5f79-d1a1-e053-2991aa0aa56d

Set id: c64a1cdd-99d6-4217-85e0-e1045046c10b

Version: 3

Effective Time: 20190328

Sungwon Pharmaceutical Co., Ltd.