Label: WALGREENS LUBRICANT EYE DROPS PRESERVATIVE FREE- 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 September 10, 2021

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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.

    Retain outer carton for full product drug facts.

  • Do not use

    Do not use if:

    This product changes color, drops should appear as a milky white solution.

  • When using this product

    • Avoid contamination, do not touch tip of container to any surface.

    • 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.
    • Squeeze 1 to 2 drops in the affeted eye(s) as needed.
    • Do not reuse. Once opened discard.
  • Other Information

    • Store between 15 o-30 oC (59 o-86 oF).
    • Store away from heat
    • Keep from freezing
    • Use only if tamper evident seals on the carton are intact and the twist top of single use container is intact.
  • Inactive ingredients

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

  • Questions or comments?

    Questions or comments?

    • 1-800-925-4733

    • 9am– 5pm EST

    Monday - Friday

  • PURPOSE

    Emollient

  • If pregnant or breast feeding

    If pregnant or breast feeding, ask a health professional before use

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

    Carton

  • INGREDIENTS AND APPEARANCE
    WALGREENS LUBRICANT EYE DROPS PRESERVATIVE FREE 
    mineral oil emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8831
    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:0363-8831-2230 in 1 CONTAINER04/11/2020
    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 finalpart34904/11/2020
    Labeler - Walgreen Company (008965063)
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