Oftal-mycin Lubricant Ophthalmic Ointment
FDA Label NDC 48201-301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grandall Distributing, Llc for the product Oftal-mycin Lubricant Ophthalmic (NDC 48201-301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, indications, warnings, otc - keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Neomycin Sulfate 0.5%

Purpose

EYE LUBRICANT

Indications

  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • may be used as a protectant against further irritation

Warnings

For external use only


When using this product

  • to avoid contamination do not touch tip of container to any surface
  • keep tube tightly closed

    • Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • wash your hands
  • pull down the lower lid of the affected eye and gently apply a small amount (1/4 inch) of ointment to the inside of eyelid, every 3-4 hours or as directed by a doctor

Inactive Ingredient

LANOLIN ALCOHOLS

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