NDC Code(s) : 24208-454-32, 24208-454-30
Packager : Bausch & Lomb Incorporated

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Advanced Eye Relief Dry Eye Rejuvenationglycerin propylene glycol SOLUTION/ DROPS
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-454
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN3 mg in 1 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
(PROPYLENE GLYCOL - UNII:6DC9Q167V3) 		PROPYLENE GLYCOL10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BORIC ACID(UNII: R57ZHV85D4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
WATER(UNII: 059QF0KO0R)
SODIUM BORATE(UNII: 91MBZ8H3QO)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24208-454-321 in 1 CARTON 09/01/2010
115 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:24208-454-301 in 1 CARTON 05/01/2017
230 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M018 09/01/2010

LABELER - Bausch & Lomb Incorporated(196603781)

Establishment
Name Address ID/FEI Business Operations
Bausch & Lomb Incorporated 114406598 manufacture(24208-454)

Establishment
Name Address ID/FEI Business Operations
Bausch & Lomb Incorporated 079587625 manufacture(24208-454)

PRINCIPAL DISPLAY PANEL

carton

BAUSCH + LOMB

ADVANCED
Eye Relief ®

Dry Eye
LUBRICANT EYE DROPS

  • Fast relief from dry eyes
  • Replenishes tears
  • Rejuvenates eyes

STERILE 1.0 FL OZ (30 mL)

6319221