Ocusan Dry Eyes
Ocusan
Approved
Approval ID
a5b9209c-0187-9d5e-e053-2a95a90a20a6
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
DLC Laboratories, Inc.
DUNS: 093351930
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 400, Propylene Glycol
PRODUCT DETAILS
NDC Product Code24286-1292
Application NumberM018
Marketing CategoryC200263
Route of AdministrationOPHTHALMIC
Effective DateApril 18, 2025
Generic NamePolyethylene Glycol 400, Propylene Glycol
INGREDIENTS (9)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLENE GLYCOLActive
Quantity: 3 mg in 1 mL
Code: 6DC9Q167V3
Classification: ACTIB
POLYETHYLENE GLYCOL 400Active
Quantity: 4 mg in 1 mL
Code: B697894SGQ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 5/15/2020
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 5/15/2020
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/20/2019
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 5/15/2020
WARNINGS SECTION
LOINC: 34071-1Updated: 5/15/2020
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 5/15/2020
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 5/15/2020
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 5/15/2020
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 5/15/2020