Label: RAPIDCARE STERILE EYEWASH- purified 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 October 28, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Purified water 98.577%

  • 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 wound 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 doctorif

    • 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

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

  • INACTIVE INGREDIENT

    Inactive ingredients 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: Rapid Care, Inc.

    Carlsbad, CA 92011

    www.rapidcarefirstaid.com

    Made in U.S.A.

    Store out of direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    RapidCare
    Sterile Eye Wash
    NDC 59276-602-80
    16 Fl OZ (474 mL)

    59276-602 Eyewash

  • INGREDIENTS AND APPEARANCE
    RAPIDCARE STERILE EYEWASH 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59276-602
    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:59276-602-80474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2020
    2NDC:59276-602-90947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/28/2021
    3NDC:59276-602-0215 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/15/2020
    Labeler - Oliver Landon Intl Inc. (815240195)
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