Label: A-MED- eyewash additive solution, concentrate

  • 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 March 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Purified water USP 97% 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 Chlorhexidine gluconate

  • 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 59276-330-04

    Eyewash Additive Concentrate

    Antimicrobial preservative for a self-contained, emergency eyewash station.
    Preserves from 5 – 20 US Gallons (18.9 – 75.7 Liters)

    4 fl. oz. (118 ml)

    A-Med Eyewash Additive Label
  • INGREDIENTS AND APPEARANCE
    A-MED 
    eyewash additive solution, concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59276-330
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER97 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59276-330-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/01/2022
    Labeler - Oliver Landon Intl Inc. (815240195)
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