Active Ingredient
Sodium Chloride, 50 mg (5%)
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent Ointment
FDA Label NDC 59390-184
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 Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent (NDC 59390-184). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep this and all drugs out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hypertonicity Agent
Use
• For the temporary relief of corneal edema.
Warnings
• For use in the eyes only.
• Retain carton for full product drug facts.
Do Not Use
this product except under the advice and supervision of a doctor.
When Using This Product
• avoid contamination, do not touch tip of container to any surface.
• replace cap after each use.
• this product may cause temporary burning and irritation on being instilled into the eye.
Stop Use And Ask A Doctor If
• you experience eye pain, changes in vision, continued redness or irritation of the eye.
• the 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(s), apply a small amount (1/4 inch) to the inside of eyelid and apply every 3-4 hours, or as directed by a doctor.
Other Information
• Store at room temperature 15°- 30°C (59°- 86°F).
• Do not freeze.
• Keep tightly closed.
• See crimp of tube or box for lot number and expiration date.
Inactive Ingredients
Lanolin Alcohol, Mineral Oil, Water for Injection and White Petrolatum.
Questions Or Comments?
•1- 800-258-2471
•9 AM-5 PM EST
Monday – Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEALS ON SIDE FLAPS ARE
NOT INTACT AND COMPLETELY LEGIBLE.
Mfd. by:
™ALTAIRE Pharmaceuticals, Inc.
Aquebogue, N.Y. 11931
Principal Display Panel
Compare to the active ingredient in MURO128®*
ISolutions™
Activeyes®
ALTACHLORE
Sodium Chloride
Hypertonicity
Ophthalmic
Ointment 5%
•FOR TEMPORARY RELIEF OF CORNEAL EDEMA
Sterile
NET WT 3.5g (1/8 OZ)
*This product is not manufactured or distributed by Bausch & Lomb, Inc., owner of the registered trademark MURO128®
Compare To The Active Ingredient In Muro128®*isolutions™activeyes®altachloresodium Chloride Hypertonicity Ophthalmic Ointment 5%•for Temporary Relief Of Corneal Edemasterile Net Wt 3.5g (1/8 Oz)*this Product Is Not Manufactured Or Distributed By Bausch & Lomb, Inc., Owner Of The Registered Trademark Muro128® (Altachlore Sodium Chloride Hypertonicity Ophthalmi 01)
* Please review the disclaimer below.
