COLIRIO OJO DE AGUILA EYE DROPS- glycerin, naphazoline hydrochloride solution/ drops COLIRIO OFTAL-MYCIN- glycerin, naphazoline hydrochloride solution/ drops

Colirio Oftal-Mycin by

Drug Labeling and Warnings

Colirio Oftal-Mycin by is a Otc medication manufactured, distributed, or labeled by Grandall Distributing Co., Inc., KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purpose

Lubricant and redness reliever

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

Warnings

For external use only

Do not use this product if

• solution changes color or becomes cloudy

Ask a doctor before use

if you have narrow angle glaucoma

When using this product

• 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

• 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.

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

Directions

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

Other information

store at room temperature

Inactive ingredients

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

Questions or Comments?

Call 1-800-344-2422

www.grandall.com

Colirio Ojo De Aguila Eye Drops 15mL

Colirio Oftal-Mycin 15mL

INGREDIENTS AND APPEARANCE

COLIRIO OJO DE AGUILA EYE DROPS 
glycerin, naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-106
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.012 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48201-106-01	1 in 1 BOX	01/01/2024
1		15 mL in 1 BOTTLE, DROPPER; 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	01/01/2024

COLIRIO OFTAL-MYCIN 
glycerin, naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-107
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.012 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48201-107-01	1 in 1 BOX	01/01/2024
1		15 mL in 1 BOTTLE, DROPPER; 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	01/01/2024

Labeler - Grandall Distributing Co., Inc. (044428324)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(48201-106, 48201-107) , pack(48201-106, 48201-107) , label(48201-106, 48201-107)