SALINAAX EYE WASH- water rinse 
Aaxis Pharmaceuticals Inc Dba Aaxis Pacific

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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Active Ingredient

Purified water USP 98.6%

Purpose

Eye Wash

Uses:

For irrigating the eye to help relieve irritation by removing loose foreign material, air pollutants, and chlorinated water.

Warnings

Do not use

  • If solution changes color or becomes cloudy
  • If snap off top is broken or missing

When using this product

  • Remove contact lenses before use
  • Do not touch the tip of container to any surface to acoid contamination

Stop use and consult a doctor

  • If you experience eye pain, change in vision, continued redness or irritation of the eye
  • If condition worsens or persists
  • If there are open wounds in or near the eye

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Storage

Store out of direct sunlight between 590F and 860F (150C and 300C)

Inactive Ingredients:

PHMB,Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

Questions

Tel: 1-424-263-5294

Principal Display Panel

NDC numbers - 68276-006-01, 02, 03, 04, 05

Salinaax

EYE WASH

Sterile Buffered Isotonic Solution with Preservative

For emergency eye cleaning and First Aid use.

Cleans, refreshes, soothes

TAMPER-EVIDENT CAP
DO NOT USE IF SNAP-OFF TOP IS BROKEN OR MISSING


STERILEA

Sterile using aseptic processing technique

68786-006-05.......... 0.5 fl.oz (15mL)

68786-006-01.......... 5.0 fl.oz (148mL)

68786-006-02.......... 8.0 fl.oz (236mL)

68786-006-03.......... 16 fl.oz (472mL)

68786-006-04.......... 32 fl.oz (944mL)

Label

SALINAAX  EYE WASH
water rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68276-006
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Potassium phosphate, monobasic (UNII: 4J9FJ0HL51)  
Sodium chloride (UNII: 451W47IQ8X)  
Sodium hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68276-006-01148 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
2NDC:68276-006-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
3NDC:68276-006-03472 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
4NDC:68276-006-04944 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
5NDC:68276-006-0515 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/18/2010
Labeler - Aaxis Pharmaceuticals Inc Dba Aaxis Pacific (049082677)
Registrant - Opto-Pharm Pte Ltd (595239682)

Revised: 4/2018
Document Id: 0de2908f-2b9b-414b-9be8-68e26f5a39b6
Set id: af98b38e-4f2c-431a-a57b-fc03387da51d
Version: 8
Effective Time: 20180424
 
Aaxis Pharmaceuticals Inc Dba Aaxis Pacific