Label: PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH- purified water 98.3% solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 1, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients

    Purified Water 98.3%

  • PURPOSE

    Purpose

    Eyewash

  • INDICATIONS & USAGE



    Use

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

  • WARNINGS

    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

    • changes in vision
    • eye pain
    • condition worsens or persists
    • continued redness or irritation of the eye
  • KEEP OUT OF REACH OF CHILDREN

     

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

  • DOSAGE & ADMINISTRATION

    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.
  • INFORMATION FOR PATIENTS

    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 INGREDIENT

    Inactive ingredients

    boric acid, sodium borate, sodium chloride

  • QUESTIONS

    Questions? Call 1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    Physicians Care 8oz NDC 0924-0162 New Label 11-2018Physicians Care 8oz NDC 0924-0162 New Label 11-2018

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH 
    purified water 98.3% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0162(NDC:65785-162)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER929 g  in 946 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:0924-0162-08236 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product06/28/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230506/24/2013
    Labeler - Acme United Corporation (001180207)
    Registrant - Niagara Pharmaceuticals, Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0162) , repack(0924-0162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation Vancouver Division080119599relabel(0924-0162) , repack(0924-0162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals, Inc.205477792manufacture(0924-0162)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!