Label: EYEWASH solution
- NDC Code(s): 78641-786-67, 78641-786-68
- Packager: Global Equipment Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 17, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Warnings
- Use
- Stop use and ask a doctor if you have any of the following
- Keep out of reach of children
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Directions
- remove tamper evident seal and cap
- avoid contamination of rim and inside surfaces of the nozzle
- place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle
- open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash
- Other information
- Inactive ingredients
- Questions?
-
Dosage and Administration
- remove tamper evident seal and cap
- avoid contamination of rim and inside surfaces of the nozzle
- place nozzle to the affected area and tilt the bottle to pour liquid out through the nozzle
- open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash
- Warnings
- Package Label.Principal Display Panel
-
INGREDIENTS AND APPEARANCE
EYEWASH
eyewash solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78641-786 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 465 mL in 473 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78641-786-67 473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product 06/17/2021 2 NDC:78641-786-68 946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product 06/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022305 06/17/2021 Labeler - Global Equipment Company (001472216) Registrant - Global Equipment Company (001472216) Establishment Name Address ID/FEI Business Operations Niagara Pharmaceuticals, Inc. 205477792 manufacture(78641-786)