Label: RETAINE MGD- mineral oil emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 31, 2024

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

  • Active ingredients

    Light Mineral Oil (0.5%)............................Emollient

    Mineral Oil (0.5%)......................................Emollient

  • Uses

    For use as a protectant against further irritation or to relieve dryness of the eye.

  • Warnings

    For use in the eyes only.

  • Do not use

    • if this product changes color.
  • When using this product

    • do not touch tip of container to any surface to avoid contamination.
    • do not reuse once opened.
  • Stop use and ask a doctor if

    • you feel eye pain or changes in vision, continued redness or irritation of the eye.
    • the condition worsens or persists for more than 72 hours.
  • KEEP OUT OF THE REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Shake well before using.
    • Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
  • Other information

    • Use only if tamper seals on top and bottom flaps are intact.
    • Drops appear as a milky white emulsion.
    • Store between 15 o-30 oC (59 o-86 oF).
  • Inactive ingredients

    Cetrimonium Bromide, glycerin, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.

  • Questions?

    Call (800) 233-5469 M-F 8:30AM-5:30PM CST
    or visit www.ocusoft.com

  • PURPOSE

  • PRINCIPAL DISPLAY PANEL - 30 sterile Single-Dose Containers

    NDC 54799-917-30

    OCuSOFT®

    COMPLETE
    DRY EYE RELIEF


    Lubricant Eye Drops

    Preservative-Free
    Relieves Irritation
    Long-Lasting Comfort

    Advanced
    Formula


    Superior Dry Eye Relief
    Without A Prescription


    30 Sterile
    Single-Dose Containers
    0.01 fl oz (0.4 mL) each


    Retaine® MGD® is a
    preservative-free ophthalmic
    emulsion that delivers
    complete Dry Eye relief
    utilizing a proprietary oil in
    water emulsion technology
    (microemulsification) with
    electrostatic attraction to
    restore the three layers of the
    tear film without blurring.

    Replenishes LIPID LAYER and
    reduces tear evaporation

    Adds moisture to AQUEOUS
    LAYER


    Lubricates and protects
    MUCIN LAYER

    Positively Charged
    Retaine® MGD®
    Droplets

    Negatively Charged
    Ocular Surface

    Use only if twist top of single-dose
    container is intact.


    OCuSOFT®
    Manufactured for OCuSOFT Inc.,
    Rosenberg, TX 77471 USA
    © 2024 OCuSOFT Inc.
    www.ocusoft.com
    Patent-Pending Formula

    Retaine® MGD® are registered trademarks
    of OCuSOFT Inc.

    Carton Label
  • INGREDIENTS AND APPEARANCE
    RETAINE MGD 
    mineral oil emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54799-917
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP) LIGHT MINERAL OIL2 mg  in 0.4 mL
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL2 mg  in 0.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cetrimonium Bromide (UNII: L64N7M9BWR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    TYLOXAPOL (UNII: Y27PUL9H56)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54799-917-3030 in 1 CONTAINER01/05/2012
    10.4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/05/2012
    Labeler - OCuSOFT, Inc. (174939207)
    Registrant - OCuSOFT, Inc. (174939207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unither Manufacturing LLC079176615analysis(54799-917) , label(54799-917) , manufacture(54799-917) , pack(54799-917)