Sterile Isotonic Buffered Genuine Eyewash: Package Insert and Label Information

STERILE ISOTONIC BUFFERED GENUINE EYEWASH — water liquid
Genuine First Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient:

Purified Water USP…q.s.

Inactive Ingredients:

Sodium Chloride USP 44mg

Monobasic Sodium Phosphate USP 18mg


Edetate Disodium USP 10mg
Benzalkonium Chloride 0.5mg
NF (as preservative)

Store in a cool place. For irrigation only.

Discard unused portion of the solution.

Not for injection.

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.


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.

Uses:
For flushing or irrigating the eyes to
remove loose foreign material, air pollutants,
or chlorinated water.

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:

10ml

Sterile Isotonic Buffered Genuine

Eyewash

For single use only

eyewash10ml
(click image for full-size original)
STERILE ISOTONIC BUFFERED GENUINE EYEWASH water liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0005
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 98.16 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0005-1 10 mL in 1 BOTTLE None
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 Operations
Stericon Pharma Pvt. Ltd. 916147736 manufacture

Revised: 07/2010 Genuine First Aid

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