Statrol label

Statrol

Statrol Recall

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Side Effects & Adverse Reactions

NOT FOR INJECTION INTO THE EYE. Should a sensitivity reaction occur, discontinue use. Neomycin Sulfate may cause cutaneous sensitization. Remove contact lenses before using.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

STRATOL Ophthalmic Solution is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis.

History

There is currently no drug history available for this drug.

Other Information

STATROLĀ® (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP) is a sterile ophthalmic drug combining two antibacterials in solution form.

Each mL of solution contains: Active: Neomycin Sulfate equivalent to 3.5 mg Neomycin base, Polymyxin B Sulfate equal to 16,250 polymyxin B units.

Preservative: Benzalkonium Chloride .004%. Vehicle: 0.5% Hydroxypropyl Methylcellulose 2910. Inactive: Boric Acid, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. DM-02

Statrol Manufacturers

  • Statrol | Alcon
    No Recall

    Statrol | Alcon

    Statrol | Alcon

    Instill one or two drops in the lower conjunctival sac(s) three or more times daily as required.

  • Statrol | Alcon Laboratories, Inc.
    No Recall

    Statrol | Alcon Laboratories, Inc.

    Statrol | Alcon Laboratories, Inc.

    Instill about a half-inch ribbon into the conjunctival sac(s) up to three or four times daily, or may be used adjunctively with the solution at bedtime.