Altachlore Sodium Chloride Hypertonicity Solution/ Drops
FDA Label NDC 59390-183

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 (NDC 59390-183). 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 out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium Chloride 5%

Purpose

Hypertonicity Agent

Use

  • For the temporary relief of corneal edema.

Warnings

For use in the eyes only

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Do Not Use

  • except under the advice and supervision of a doctor.
  • if solution changes color or becomes cloudy.

When Using This Product

  • keep tightly closed.
  • to avoid contamination, do not touch tip of container to any surface.
  • replace cap immediately 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 your vision occur.
  • continued redness or irritation of the eye persists.
  • condition worsens or persists.

Keep Out Of Reach Of Children.

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

Directions

  • instill 1 or 2 drops in the affected eye(s) every 3 to 4 hours, or as directed by a doctor.

Other Information

  • replace cap after using and keep tightly closed.
  • store at 15° to 30°C (59° to 86°F).
  • remove contact lenses before using.

Inactive Ingredients

Boric Acid, Hypromellose, Methylparaben, Propylene Glycol, Proplyparaben, Sodium Borate, and Water for injection. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH.

Questions?

  • 1 (800) 258-2471 
  • 9am– 5pm EST Monday - Friday

Principal Display Panel

iSolutions
ActivEyes
Altachlore 
5% Solution
Sodium Chloride
Hypertonicity Ophthalmic
Solution 5%
Sterile 15mL
NET WT (1/2 FL OZ)

Principal Display Panelisolutionsactiveyesaltachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5%sterile 15mlnet Wt (1/2 Fl Oz) (Altachlore Sodium Chloride Hypertonicity Ophthalmi 01)

Principal Display Panelisolutionsactiveyesaltachlore 5% Solution Sodium Chloride Hypertonicity Ophthalmic Solution 5%sterile 15mlnet Wt (1/2 Fl Oz) (Altachlore Sodium Chloride Hypertonicity Ophthalmi 01)

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