Label: FIRSTEP FIRSTFLUSH- eyewash solution
- NDC Code(s): 70290-310-32
- Packager: Encon Safety Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 28, 2020
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- Active ingredient
- Purpose
- Warnings
- Use
- Stop use and ask a doctor if you have any of the following
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions?
- Dosage and Administration
- Warnings
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INGREDIENTS AND APPEARANCE
FIRSTEP FIRSTFLUSH
eyewash solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70290-310 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:70290-310-32 946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product 04/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022305 04/27/2020 Labeler - Encon Safety Products, Inc. (008102410) Registrant - Niagara Pharmaceuticals, Inc. (205477792) Establishment Name Address ID/FEI Business Operations Niagara Pharmaceuticals, Inc. 205477792 manufacture(70290-310)