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.

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Sterile Isotonic Buffered Genuine Eyewash

Active Ingredient:

Purified Water USP...q.s.

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)


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
STERILE ISOTONIC BUFFERED GENUINE EYEWASH 
water liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0005
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.16 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52124-0005-110 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/16/2010
Labeler - Genuine First Aid (619609857)
Establishment
NameAddressID/FEIBusiness Operations
Stericon Pharma Pvt. Ltd.916147736manufacture

Revised: 7/2010
Document Id: c7bbb831-ecd8-4c13-8aa7-02c2b8f99f1f
Set id: d5b64599-dd03-47ea-b538-1836aee2cac4
Version: 10
Effective Time: 20100712
 
Genuine First Aid