Label: STERILE SALINE EYEWASH- water solution

  • 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 June 1, 2017

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  • Active Ingredient

    water 98.7%

    Purpose

    eyewash

  • Warnings

    Do not use if solution changes color or becomes cloudy.remove contact lenses before use.stop use if eye pain continued redness or irritation of eye .

    Keep out of reach of children.

    Keep out of reach of children.in case of axxidental ingestion,seek professional assistance or consult a poison control center immediately.

  • Directions

    Twist top to open,Flush eye as needed.

  • Use

    for irrigating the eye to help relieve irritation by removeing loose foreign material.

  • Inactive Ingredients

    Sodium chloride ,Potassium phosphate monobasic ,Sodium hydroxide,POLIHEXANIDE

  • PRINCIPAL DISPLAY PANEL

    6

  • INGREDIENTS AND APPEARANCE
    STERILE SALINE EYEWASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71222-006
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.987 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE (UNII: 322U039GMF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71222-006-0110 mL in 1 PACKAGE; Type 0: Not a Combination Product05/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34905/20/2014
    Labeler - Tongzhou Deqi Medical Products Factory (544464252)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tongzhou Deqi Medical Products Factory544464252manufacture(71222-006)
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