NDC Code(s) : 24208-507-07, 24208-507-02, 24208-507-01
Packager : Bausch & Lomb Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lotemax SMloteprednol etabonate GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-507
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOTEPREDNOL ETABONATE(UNII: YEH1EZ96K6)
(LOTEPREDNOL - UNII:Z8CBU6KR16) 		LOTEPREDNOL ETABONATE3.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BORIC ACID(UNII: R57ZHV85D4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLOXAMER 407(UNII: TUF2IVW3M2)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24208-507-071 in 1 CARTON 25/02/2019
15 g in 1 BOTTLE Type 0: Not a Combination Product
2NDC:24208-507-021 in 1 CARTON 25/02/2019
25 g in 1 BOTTLE Type 0: Not a Combination Product
3NDC:24208-507-011 in 1 CARTON 25/02/2019
30.5 g in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208219 02/25/2019

LABELER - Bausch & Lomb Incorporated(196603781)

Establishment
Name Address ID/FEI Business Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-507), PACK(24208-507), LABEL(24208-507)

PRINCIPAL DISPLAY PANEL

NDC 24208-507-07

Rx only

Lotemax® SM

(loteprednol etabonate

Ophthalmic gel) 0.38%

FOR OPHTHALMIC USE ONLY

Sterile

5 g

Carton