Salinaax
FDA Label NDC 68276-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aaxis Pharmaceuticals Inc Dba Aaxis Pacific for the product Salinaax (NDC 68276-006). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                                       Purpose:

Purified water USP98.6%............................................Eye Wash

Otc - Purpose

Purpose: eye wash

Indications & Usage

Uses:  For irrigating the eye to help relieve irritation by removing loose foreign material, air pollutants, and chlorinated water.

Warnings

Warning:

For external use only

  • To avoid contamination, do not touch tip of container to any surface
  • Do not reuse.  Once opened, discard any unused solution immediately, do not transfer to other containers
  • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor
  • If solution changes color or becomes cloudy, do not use
  • Obtain immediate medical treatment for all open wounds in or near the eyes

Otc - Do Not Use

Do Not Use:

  •  For injection
  •  While wearing contact lenses
  •  If eye is lacerated or object is embedded
  •  If snap-off is broken or missing

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Dosage & Administration

Directions:

  • Twist snap-off top to open
  • Flush affected eye as needed, controlling the rate of flow of solution by pressure on the container
  • Discard container after use

Storage And Handling

Other Information:

Store out of direct sunlight between 59 degrees F and 86 degrees F (15 degrees C and 30 degrees C)

Inactive Ingredient

Inactive Ingredients:

PHMB,Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

Package Label.Principal Display Panel



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