Label: REAL EYEWASH- purified water solution
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Contains inactivated NDC Code(s)
NDC Code(s): 59276-208-10, 59276-208-12, 59276-208-14, 59276-208-16, view more59276-208-18, 59276-208-20, 59276-208-21, 59276-208-30, 59276-208-31, 59276-208-40, 59276-208-41, 59276-208-50, 59276-208-51, 59276-208-60, 59276-208-61, 59276-208-70, 59276-208-71, 59276-208-80, 59276-208-81, 59276-208-82, 59276-208-90, 59276-208-91, 59276-208-92 - Packager: Oliver Landon Intl Inc.
- 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 November 10, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REAL EYEWASH
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59276-208 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.577 mL in 100 mL Inactive Ingredients Ingredient Name Strength POLIHEXANIDE (UNII: 322U039GMF) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59276-208-12 5 in 1 BOX 04/13/2018 1 NDC:59276-208-10 15 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 2 NDC:59276-208-14 10 in 1 BOX 04/13/2018 2 NDC:59276-208-10 15 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 3 NDC:59276-208-16 30 in 1 BOX 04/13/2018 3 NDC:59276-208-10 15 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 4 NDC:59276-208-18 60 in 1 BOX 04/13/2018 4 NDC:59276-208-10 15 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 5 NDC:59276-208-21 4 in 1 BOX 04/13/2018 5 NDC:59276-208-20 30 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 6 NDC:59276-208-31 1 in 1 BOX 04/13/2018 6 NDC:59276-208-30 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 7 NDC:59276-208-41 1 in 1 BOX 04/13/2018 7 NDC:59276-208-40 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 8 NDC:59276-208-51 1 in 1 BOX 04/13/2018 8 NDC:59276-208-50 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 9 NDC:59276-208-61 1 in 1 BOX 04/13/2018 9 NDC:59276-208-60 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10 NDC:59276-208-71 1 in 1 BOX 04/13/2018 10 NDC:59276-208-70 350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 11 NDC:59276-208-81 1 in 1 BOX 04/13/2018 11 NDC:59276-208-80 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12 NDC:59276-208-82 2 in 1 BOX 04/13/2018 12 NDC:59276-208-80 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 13 NDC:59276-208-91 1 in 1 BOX 04/13/2018 13 NDC:59276-208-90 947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 14 NDC:59276-208-92 2 in 1 BOX 04/13/2018 14 NDC:59276-208-90 947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 04/13/2018 Labeler - Oliver Landon Intl Inc. (815240195)