Goodsense Irritation Relief Eye
FDA Label NDC 50804-018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc. for the product Goodsense Irritation Relief Eye (NDC 50804-018). 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, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ Storage And Handling

→ Inactive Ingredient

→ Dosage & Administration

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active ingredients Purpose

Tetrahydrozoline HCI 0.05.................Redness reliever

Zinc sulfate 0.25%...........................Astringent

Otc - Purpose

Uses

for temporary relief of discomfort and redness of the eye due to minor eye irritations

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have

narrow angle glaucoma.

Otc - When Using

When using this product

pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
do not use if this solution changes color or becomes cloudy
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before 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.

Indications & Usage

Directions

to open bottle, push cap down and twist counter-clockwise. To close bottle, twist clockwise until it stops turning.
put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor