Label: RETAINE MGD- mineral oil emulsion

  • 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 January 12, 2023

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

    Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.

  • Questions?

    Call (800)233-5469 M-F 8:30AM-5:00PM CST or visit www.retainebrand.com

  • PURPOSE

    Emollient

  • PRINCIPAL DISPLAY PANEL - 30 sterile Single-Dose Containers Carton

    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
    CETALKONIUM CHLORIDE (UNII: 85474O1N9D)  
    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 finalpart34901/05/2012
    Labeler - OCuSOFT, Inc. (174939207)
    Registrant - OCuSOFT, Inc. (174939207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excelvision274234566pack(54799-917) , manufacture(54799-917)
    Establishment
    NameAddressID/FEIBusiness Operations
    Servipac571772875pack(54799-917)
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