STERILE ISOTONIC BUFFERED GENUINE EYEWASH- water liquid

Sterile Isotonic Buffered Genuine Eyewash by

Drug Labeling and Warnings

Sterile Isotonic Buffered Genuine Eyewash by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid, Stericon Pharma Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Purified Water USP...q.s.

INACTIVE INGREDIENT

Inactive Ingredients:

Sodium Chloride USP                                          44mg

Monobasic Sodium Phosphate USP                18mg

Sodium Phosphate Dibasic USP                       111mg 

Edetate Disodium USP                                       10mg

Benzalkonium Chloride                                      0.5mg
NF (as preservative)

STORAGE AND HANDLING

Store in a cool place. For irrigation only.

Discard unused portion of the solution.

Not for injection.

WARNINGS

Warning:

If you experience eye pain, changes in vision, continued redness or irritation of the eye,

or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

Do not use if solution changes color or becomes cloudy.

DOSAGE & ADMINISTRATION

Directions

Remove contacts before using.

Twist top to remove.

Flush the affected area as needed. Control

Rate of flow by pressure on the bottle. Do not touch

tip of the container to any surface. Do not reuse.

If necessary continue flushing with emergency eyewash or shower.

Discard bottle after use.

PURPOSE

Uses:

For flushing or irrigating the eyes to

remove loose foreign material, air pollutants,

or chlorinated water.

DESCRIPTION

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:

PRINCIPAL DISPLAY PANEL

10ml

Sterile Isotonic Buffered Genuine

Eyewash

For single use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILE ISOTONIC BUFFERED GENUINE EYEWASH 
water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-0005
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.16 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0005-1	10 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/16/2010

Labeler - Genuine First Aid (619609857)

Establishment
Name	Address	ID/FEI	Business Operations
Stericon Pharma Pvt. Ltd.		916147736	manufacture