SALINAAX EYE WASH AND SKIN FLUSH- water rinse

Salinaax by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:
Purified water USP 98.6%

PURPOSE

Purpose:
Eye wash and skin flush

INDICATIONS & USAGE

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

WARNINGS

Warnings: For external use only. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard, do not transfer to other bottle containers. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor, obtain immediate medical treatment for all open wounds in or near the eyes. If solution changes color or becomes cloudy, do not use.

DO NOT USE

Do Not Use:For injection, with contact lenses, If eye is lacerated or object is embedded, If twist top is broken or missing.

STOP USE

If solution changes color or becomes cloud, do not use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions:Twist top to open, flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle, discard bottle after use.

STORAGE AND HANDLING

Other Information:

Store out of direct sunlight between 15 degrees C and 30 degrees C (59 degrees F - 86 degrees F)

INACTIVE INGREDIENT

Inactive Ingredients:

Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

PRINCIPAL DISPLAY PANEL

Salinaax
Tamper-evident ca do not use if twist-off or is broken or missing
Preservative free
Eye Wash and Skin Flush
Single Use Only
Sterile Buffered Isotonic Solution
5fl.oz (148ml)
Compliance: Ansi/isea
(As personal eye wash only)
AAXIS Excelling in healthcare solutions

INGREDIENTS AND APPEARANCE

SALINAAX  EYE WASH AND SKIN FLUSH
water rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68276-005
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: 68276-005-01	148 mL in 1 BOTTLE
2	NDC: 68276-005-02	236 mL in 1 BOTTLE
3	NDC: 68276-005-03	472 mL in 1 BOTTLE
4	NDC: 68276-005-04	944 mL in 1 BOTTLE
5	NDC: 68276-005-05	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/11/2011

Labeler - Aaxis Pacific (751370305)

Establishment
Name	Address	ID/FEI	Business Operations
Opto Pharm Pte Ltd		595239682	manufacture