Label: A-MED BRAND FIRST AID EYE AND SKIN-RINSE- purified water solution
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Contains inactivated NDC Code(s)
NDC Code(s): 59276-209-10, 59276-209-12, 59276-209-14, 59276-209-16, view more59276-209-18, 59276-209-21, 59276-209-22, 59276-209-30, 59276-209-31, 59276-209-40, 59276-209-41, 59276-209-50, 59276-209-60, 59276-209-61, 59276-209-70, 59276-209-71, 59276-209-80, 59276-209-81, 59276-209-82, 59276-209-90, 59276-209-91, 59276-209-92 - 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 December 5, 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
A-MED BRAND FIRST AID EYE AND SKIN-RINSE
purified water solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59276-209 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:59276-209-12 5 in 1 BOX 11/01/2013 1 15 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:59276-209-14 10 in 1 BOX 11/01/2013 12/20/2020 2 15 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:59276-209-16 30 in 1 BOX 11/01/2013 12/21/2020 3 15 mL in 1 VIAL; Type 0: Not a Combination Product 4 NDC:59276-209-18 60 in 1 BOX 11/01/2013 12/20/2020 4 15 mL in 1 VIAL; Type 0: Not a Combination Product 5 NDC:59276-209-21 4 in 1 BOX 11/01/2013 12/20/2020 5 30 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 6 NDC:59276-209-31 1 in 1 BOX 11/01/2013 12/20/2020 6 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 7 NDC:59276-209-41 1 in 1 BOX 11/01/2013 12/20/2020 7 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 8 NDC:59276-209-50 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2020 9 NDC:59276-209-61 1 in 1 BOX 11/01/2013 12/20/2020 9 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10 NDC:59276-209-71 1 in 1 BOX 11/01/2013 12/20/2020 10 350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 11 NDC:59276-209-81 1 in 1 BOX 11/01/2013 12/20/2020 11 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12 NDC:59276-209-82 2 in 1 BOX 11/01/2013 12/20/2020 12 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 13 NDC:59276-209-91 1 in 1 BOX 11/01/2013 12/20/2020 13 947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 14 NDC:59276-209-92 2 in 1 BOX 11/01/2013 12/20/2020 14 947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 15 NDC:59276-209-22 4 in 1 BOX 12/20/2020 15 15 mL in 1 VIAL; Type 0: Not a Combination Product 16 NDC:59276-209-30 30 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 12/20/2020 17 NDC:59276-209-40 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2020 18 NDC:59276-209-60 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2020 19 NDC:59276-209-70 350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/20/2020 20 NDC:59276-209-90 947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2020 21 NDC:59276-209-80 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/20/2020 22 NDC:59276-209-10 15 mL in 1 VIAL; Type 0: Not a Combination Product 11/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 11/01/2013 Labeler - Oliver Landon Intl Inc. (815240195)