FDA.reportPublic FDA data

Colirio Oftal-Mycin

Manufacturer
Grandall Distributing Co., Inc. | KC Pharmaceuticals, Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:37

Label at a glance#

ProductColirio Ojo De Aguila Eye Drops
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

relieves redness of the eye due to minor eye irritations for use as a protectant against further irritation or to relieve dryness of the eye temporarily relieves burning and irritation due to dryness of the eye

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purpose

OTC - PURPOSE SECTION

Lubricant and redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • temporarily relieves burning and irritation due to dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use this product if

OTC - DO NOT USE SECTION

  • solution changes color or becomes cloudy

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
  • overuse may cause more redness of the eye
  • pupils may become enlarged temporarily

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens
  • symptoms last for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information

OTHER SAFETY INFORMATION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-344-2422

www.grandall.com

Colirio Ojo De Aguila Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colirio Ojo De Aguila Eye Drops 15mLColirio Ojo De Aguila Eye Drops 15mL

Colirio Oftal-Mycin 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colirio Oftal-Mycin 15mLColirio Oftal-Mycin 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSN2
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCD2
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130348201016131GTIN-13: 0348201016131
EAN-13: 0348201016131
GTIN-12: 348201016131
UPC-A: 348201016131
GTIN storage (14 digits): 00348201016131		Colirio Oftal-Mycin_EDRL_DG.jpg
BarcodeEAN-130348201016155GTIN-13: 0348201016155
EAN-13: 0348201016155
GTIN-12: 348201016155
UPC-A: 348201016155
GTIN storage (14 digits): 00348201016155		Colirio Ojo De Aguila Eye Drops_EDRL_GR.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-106-01Colirio Ojo De Aguila Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
48201-106-01Colirio Ojo De Aguila Eye Drops1 in 1 BOXSOLUTION/ DROPS12
48201-107-01Colirio Oftal-Mycin15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
48201-107-01Colirio Oftal-Mycin1 in 1 BOXSOLUTION/ DROPS12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48201-10648201-106-01
48201-10748201-107-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
GLYCERINPDC6A3C0OXACTIB
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
GLYCERINPDC6A3C0OXACTIB
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
ndc (package): 48201-106-01
ndc (package): 48201-107-01
ndc (product): 48201-107
ndc (product): 48201-106
ndc11 (package): 48201010601
ndc11 (package): 48201010701
spl id: 4741a1f5-e262-8d85-e063-6394a90a014c
spl set id: 31aa07e9-0cc9-2a77-e063-6394a90a4b9d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.