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Salinaax Eye Wash and Skin Flush

Dosage form: rinse
Ingredients: Water 98.6mL in 100mL
Labeler: Aaxis Pacific
NDC Code: 68276-005

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 Ingredients:
Purified water USP 98.6%

Purpose:
Eye wash and skin flush

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

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:For injection, with contact lenses, If eye is lacerated or object is embedded, If twist top is broken or missing.

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

Keep out of reach of children.

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

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.

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

Inactive Ingredients:
Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

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
SALINAAX  EYE WASH AND SKIN FLUSH
water rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68276-005
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Water (Water) Water98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Potassium phosphate, monobasic 
Sodium chloride 
Sodium hydroxide 
Packaging
#Item CodePackage Description
1NDC:68276-005-01148 mL in 1 BOTTLE
2NDC:68276-005-02236 mL in 1 BOTTLE
3NDC:68276-005-03472 mL in 1 BOTTLE
4NDC:68276-005-04944 mL in 1 BOTTLE
5NDC:68276-005-0515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/11/2011
Labeler - Aaxis Pacific (751370305)
Establishment
NameAddressID/FEIOperations
Opto Pharm Pte Ltd595239682manufacture

Revised: 03/2011
Document Id: 80984d7b-efbd-452b-aea4-8f1d83d5ee25
Set id: e5ed271a-46e7-479a-b603-3e5c6f38815f
Version: 5
Effective Time: 20110311
 
Aaxis Pacific

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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