Label: A-MED BRAND FIRST AID EYE AND SKIN-RINSE- purified water solution

  • Contains inactivated NDC Code(s)
    NDC Code(s):     59276-209-10, 59276-209-12, 59276-209-14, 59276-209-16, view more
    59276-209-18, 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

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Purified water USP 98.577% w/v

  • PURPOSE

    Purpose

    Eyewash

  • INDICATIONS & USAGE

    Use for flushing the eye to remove loose foreign material.

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy
    • if you have open wounds in or near the eyes. Get medical help right away.

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • do not reuse; once opened, discard

    Stop use and ask a doctor if​

    • continued redness or irritation of the eye

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

  • INACTIVE INGREDIENT

    Inactive ingredients disodium disodium EDTA, polyhexanide 0.0001% (preservative), sodium chloride, sodium phosphate dibasic dodecahydrate, sodium phosphate, monobasic dihydrate. Sodium hydroxide may be used to adjust pH.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Oliver Landon Intl Inc.

    21 Pine Road, Belleville, St. Michael

    BB 11113 Barbados

    Questions or concerns:

    email - info@oliverlandon.biz or call (800) 839-5929

    Made in U.S.A.

    Store out of direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    A-Med Wash

    NDC 59276-209-80

    First Aid Eye Rinse

    16 FL OZ (474 mL)

    59276-209 US

  • INGREDIENTS AND APPEARANCE
    A-MED BRAND FIRST AID EYE AND SKIN-RINSE 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59276-209
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.577 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59276-209-125 in 1 BOX11/01/2013
    115 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:59276-209-1410 in 1 BOX11/01/201312/20/2020
    215 mL in 1 VIAL; Type 0: Not a Combination Product
    3NDC:59276-209-1630 in 1 BOX11/01/201312/21/2020
    315 mL in 1 VIAL; Type 0: Not a Combination Product
    4NDC:59276-209-1860 in 1 BOX11/01/201312/20/2020
    415 mL in 1 VIAL; Type 0: Not a Combination Product
    5NDC:59276-209-214 in 1 BOX11/01/201312/20/2020
    530 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    6NDC:59276-209-311 in 1 BOX11/01/201312/20/2020
    6118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:59276-209-411 in 1 BOX11/01/201312/20/2020
    7118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    8NDC:59276-209-50148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2020
    9NDC:59276-209-611 in 1 BOX11/01/201312/20/2020
    9236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:59276-209-711 in 1 BOX11/01/201312/20/2020
    10350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    11NDC:59276-209-811 in 1 BOX11/01/201312/20/2020
    11474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    12NDC:59276-209-822 in 1 BOX11/01/201312/20/2020
    12474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    13NDC:59276-209-911 in 1 BOX11/01/201312/20/2020
    13947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    14NDC:59276-209-922 in 1 BOX11/01/201312/20/2020
    14947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    15NDC:59276-209-224 in 1 BOX12/20/2020
    1515 mL in 1 VIAL; Type 0: Not a Combination Product
    16NDC:59276-209-3030 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product12/20/2020
    17NDC:59276-209-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2020
    18NDC:59276-209-60236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2020
    19NDC:59276-209-70350 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/20/2020
    20NDC:59276-209-90947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2020
    21NDC:59276-209-80474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2020
    22NDC:59276-209-1015 mL in 1 VIAL; Type 0: Not a Combination Product11/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/01/2013
    Labeler - Oliver Landon Intl Inc. (815240195)
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