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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24286-1292
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Polyethylene Glycol 400, Propylene Glycol
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 18, 2025
FDA Product Classification
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