SALINAAX EYE WASH- water rinse

Salinaax by

Drug Labeling and Warnings

Salinaax by is a Otc medication manufactured, distributed, or labeled by Aaxis Pharmaceuticals Inc Dba Aaxis Pacific, Opto-Pharm Pte Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Twist snap-off top to open
• Flush affected eye as needed, controlling the rate of flow of solution by pressure on the container
• DO not reuse
• Discard container after use

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)

INGREDIENTS AND APPEARANCE

SALINAAX  EYE WASH
water rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68276-006
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	98.6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Potassium phosphate, monobasic (UNII: 4J9FJ0HL51)
Sodium chloride (UNII: 451W47IQ8X)
Sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68276-006-01	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2010
2	NDC: 68276-006-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2010
3	NDC: 68276-006-03	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2010
4	NDC: 68276-006-04	944 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2010
5	NDC: 68276-006-05	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/18/2010

Labeler - Aaxis Pharmaceuticals Inc Dba Aaxis Pacific (049082677)

Registrant - Opto-Pharm Pte Ltd (595239682)