Label: EYE IRRIGATING- purified water solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-0382-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0536-0901
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated September 27, 2017
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
Do not use if solution changes color or becomes cloudy
When using this product
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- remove contact lenses before use
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- do not touch tip of container to any surface to avoid contamination
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- replace cap after use
Stop use and ask a doctor if
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- you experience eye pain, changes in vision, continued redness or irritation of the eye
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- condition worsens or persists
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- you have open wounds in or near the eye
- Keep out of reach of children.
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Directions
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- flush the affected eye(s) as needed
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- control the rate of flow of solution by placing pressure on the bottle
When using an eye cup
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- rinse the cup with clean water immediately before each use
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- avoid contamination of the rim and inside surfaces of the cup
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- fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
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- tilt the head backward. Open eyelid wide and rotate eyeball to ensure thorough bathing with the wash
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- rinse the cup with clean water after each use
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- Purified Water
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INGREDIENTS AND APPEARANCE
EYE IRRIGATING
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0382(NDC:0536-0901) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 99.05 mL in 100 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0382-0 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/07/2011 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0382)
