Altalube Ointment
FDA Label NDC 59390-198

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Altaire Pharmaceuticals Inc. for the product Altalube (NDC 59390-198). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep this and all drugs out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Mineral Oil 15% and White Petrolatum 85%

Purpose

Eye Lubricant

Uses

• as a lubricant to prevent further irritation  • to relieve dryness of the eye(s).

Warnings

• For use in the eyes only.   • Save box for complete information.

When Using This Product

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

• replace cap after each use.

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.

Keep This And All Drugs Out Of The Reach Of Children.

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

Directions

• pull down lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid every 3-4 hours or as directed by a doctor.

Other Information

• store at room temperature 15°-30°C (59°-86°F). • protect from freezing.

• see crimp of tube or box for lot number and expiration date.

• keep tightly closed.

• does not contain preservatives.

Inactive Ingredients

None remove

Questions Or Comments?

• (631) 722-5988 • 9AM – 5 PM EST Monday- Friday

Principal Display Panel

ActiEyes
Altalube Ointment
White Petrolatum
and Mineral Oil
Lubricant Eye Ointment
Preservative Free
Sterile
NET WT
3.5g (1/8 OZ)

Actieyes Altalube Ointmentwhite Petrolatum And Mineral Oillubricant Eye Ointment Preservative Freesterilenet Wt3.5g (1/8 Oz) (Altalube Ointment 01)

Actieyes Altalube Ointmentwhite Petrolatum And Mineral Oillubricant Eye Ointment Preservative Freesterilenet Wt3.5g (1/8 Oz) (Altalube Ointment 01)

* Please review the disclaimer below.