NDC Code(s) : 76058-107-01, 76058-107-02
Packager : Sungwon Pharmaceutical Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ESIRIN X Sodium Monofluorophosphate PASTE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76058-107
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Monofluorophosphate(UNII: C810JCZ56Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.4 g in 200 g
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76058-107-021 in 1 CARTON
1NDC:76058-107-01200 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/31/2013

PRINCIPAL DISPLAY PANEL

image of Esirin