Artificial Tears
FDA Label NDC 13985-600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mwi for the product Artificial Tears (NDC 13985-600). 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 other, active ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Mineral Oil
15%

White Petrolatum
83%

Purpose

Eye lubricant

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eyes.

Warnings

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Otc - Stop Use

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep 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(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

Other Information

  • Store at 20° to 25°C (68° to 77°F)
    [see USP controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredient

Lanolin 2%

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

NDC 13985-600-03

Apexa logo

Artificial Tears STERILE

Ophthalmic Lubricant Ointment

Prevents Irritation and Relieves Dryness of the eye

Can be used at bedtime

AP 704001 Net Weight: 3.5g (1/8 oz)

Principal Display Panel Text for Carton Label:

NDC 13985-600-03

Artificial Tears

Ophthalmic

Lubricant

Ointment

STERILE

Prevents Irritation

and Relieves

Dryness of the eye

Can be used

at bedtime

Apexa logo

AP 704001

Net Weight: 3.5g (1/8 oz)

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