Colirio Ocusan
Colirio Ocusan
Approved
Approval ID
0f0dd0bd-9a35-4671-933a-f3f8e834ae65
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.
TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24286-1575
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, POVIDONE, UNSPECIFIED, and DEXTRAN 70
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (10)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYETHYLENE GLYCOL 400Active
Quantity: 10 mg in 1 mL
Code: B697894SGQ
Classification: ACTIB
POVIDONE, UNSPECIFIEDActive
Quantity: 10 mg in 1 mL
Code: FZ989GH94E
Classification: ACTIB
DEXTRAN 70Active
Quantity: 1 mg in 1 mL
Code: 7SA290YK68
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TETRAHYDROZOLINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: 0YZT43HS7D
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/20/2019
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 12/20/2019
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/20/2019
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/20/2019
WARNINGS SECTION
LOINC: 34071-1Updated: 12/20/2019
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/20/2019
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 12/20/2019
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 12/20/2019
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 12/20/2019