Label: SALINAAX EYE WASH- water rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 68276-006-01, 68276-006-02, 68276-006-03, 68276-006-04, view more68276-006-05 - Packager: Aaxis Pharmaceuticals Inc Dba Aaxis Pacific
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 24, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
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Warnings
When using this product
- Remove contact lenses before use
- Do not touch the tip of container to any surface to acoid contamination
- Directions
- Storage
- Inactive Ingredients:
- Questions
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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
STERILEASterile 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)
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INGREDIENTS AND APPEARANCE
SALINAAX EYE WASH
water rinseProduct 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)