Label: VISCO SHIELD LUBRICANT (hypromellose 2208- 15000 mpa.s solution/ drops

  • 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 February 2, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hypromellose (1.7%)

  • Purpose

    Ophthalmic lubricant

  • Uses

    • For the temporary relief of burning and irritation due to dryness of the eye
    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye
  • Warnings

    • For external use only
    • To avoid contamination do not touch tip of container or applicator to any surface
    • Once opened, discard
    • Do not reuse

    Stop use and ask a doctor if

    • You experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor
    • If solution changes color or becomes cloudy, do not use

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

  • Directions

    • Remove cap from syringe and screw on applicator tip
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Questions, or comments

    (800) 631-7180 or (909) 305-5400 or log onto www.oasistears.com

  • Other information

    • Do not sue if pouch is damage or has been previously opened
    • Protect from freezing
    • Store at or below 77°F/25°C
  • Inactive Ingredients

    Calcium chloride dihydrate, hydrochloric acid1, magnesium chloride hexahydrate, potassium chloride, purified water, sodium acetate trihydrate, sodium chloride, sodium citrate dihydrate, and sodium hydroxide1

    1
    May contain one or more of these ingredients for pH adjustment
  • PRINCIPAL DISPLAY PANEL - 2 ml Syringe Carton

    VISCO SHIELD®
    Topical Drops

    Ophthalmic
    Lubricant Drops

    • Sterile
    • Preservative-free
    • Single use, disposable container

    CONTAINS: 6 Pouches, each Pouch containing
    1 Single Use Syringe, 0.07 fl oz (2 ml)
    1 Single Use Applicator Tip

    OASIS®

    OASIS® Medical, Glendora CA 91741 USA
    © 2014 OASIS Medical
    P940 3/2014

    Certain manufacturing operations have been performed by other firms

    Principal Display Panel - 2 ml Syringe Carton
  • INGREDIENTS AND APPEARANCE
    VISCO SHIELD   LUBRICANT
    hypromellose 2208 (15000 mpa.s) solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42126-5200
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) (HYPROMELLOSE 2208 (15000 MPA.S) - UNII:Z78RG6M2N2) HYPROMELLOSE 2208 (15000 MPA.S)17 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42126-5200-06 in 1 CARTON06/16/2014
    11 in 1 POUCH
    12 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34906/16/2014
    Labeler - OASIS Medical, Inc. (194121018)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS Medical, Inc.194121018MANUFACTURE(42126-5200)
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