Label: SCIENCEWARE EYEWASH- water solution

  • Category: HUMAN OTC DRUG LABEL

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 February 6, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Purified water 98.3%

  • Purpose

    Eyewash

  • Use

    For cleansing the eye to help relieve irritation or burning by removing loose foreign material

  • Warnings

    For external use only

    Do not use

    • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
    • if solution changes color or becomes cloudy

    When using this product

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

    Stop use and ask a doctor if you have any of the following

    • continued redness or irritation of the eye
    • condition worsens or persists
    • eye pain
    • changes in vision

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

  • Directions

    • remove tamper evident seal and cap
    • flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
  • Other information

    • lot number is printed on the bottle
    • store at 20° to 25°C (68° to 77°F)
    • for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"
    • do not use if this seal is missing or broken
    • use before expiration date marked on bottle
  • Inactive ingredients

    boric acid, sodium borate, sodium chloride

  • Questions?

    Call 800-423-5278 9a.m. to 5 p.m. EST Mon-Fri

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Carton

    Bel-Art
    SP SCIENCEWARE™

    EYEWASH

    Purified Water, 98.3%
    Ophthalmic Solution Eyewash

    NDC# 67691-770-11
    Single Use
    Made in Canada

    Cat. No. 24879-9032
    Bel-Art – SP Scienceware
    661 Route 23 South
    Wayne, NJ 07470

    32 fl. oz. (946 mL)

    1 800 423-5278 • www.belart.com

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SCIENCEWARE EYEWASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67691-770
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water98.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric acid (UNII: R57ZHV85D4)  
    sodium borate (UNII: 91MBZ8H3QO)  
    sodium chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67691-770-11946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34901/15/2017
    Labeler - Bel-Art (002176733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals, Inc205477792MANUFACTURE(67691-770)
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