Bouton
FDA Label NDC 68276-004

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 Bouton (NDC 68276-004). 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

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients Purpose:

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

Otc - Purpose

Purpose:

Eye Wash

Indications & Usage

Uses: For flushing/irrigating the eyes to remove loose foreign material, air pollutants, chlorinated water and to refresh irritated or tired eyes.

Warnings

Warning:

For external use only

Otc - Do Not Use

Do Not Use:

for injection
with contact lenses
if solution changes color or gets cloudy
if eye is lacerated or object is embedded
if twist top is broken or missing

Otc - Stop Use

Stop use and consult a doctor if you have:

changes in vision
continued redness in or near the eyes
eye pain
if condition worsens or persists

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, single use only