Salinaax
FDA Label NDC 68276-005

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 Pacific for the product Salinaax (NDC 68276-005). 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 - stop use, otc - keep out of reach of children, dosage & administration, 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:
Purified water USP 98.6%

Otc - Purpose

Purpose:Eye wash and skin flush

Indications & Usage

Uses: For irrigating the eyes to remove loose foreign material, air pollutants, chlorinated water and for flushing the skin.

Warnings

Warnings: For external use only. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard, do not transfer to other bottle 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, obtain immediate medical treatment for all open wounds in or near the eyes. If solution changes color or becomes cloudy, do not use.

Otc - Do Not Use

Do Not Use:For injection, with contact lenses, If eye is lacerated or object is embedded, If twist top is broken or missing.

Otc - Stop Use

If solution changes color or becomes cloud, do not use.

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 top to open, flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle, discard bottle after use.

Storage And Handling

Other Information:

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

Inactive Ingredient

Inactive Ingredients:

Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

Package Label.Principal Display Panel

SalinaaxTamper-evident ca do not use if twist-off or is broken or missingPreservative freeEye Wash and Skin FlushSingle Use OnlySterile Buffered Isotonic Solution5fl.oz (148ml)Compliance: Ansi/isea(As personal eye wash only)AAXIS Excelling in healthcare solutions

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