FDA Label for Freds Astringent Rdeness Reliever Eye
View Indications, Usage & Precautions
Freds Astringent Rdeness Reliever Eye Product Label
The following document was submitted to the FDA by the labeler of this product Freds Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Tetrahydrozoline HCl 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
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 tips 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 they 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
- Instill 1 or 2 drops in the affected eye(s) up to 4 times daily
- Children under 6 years of age: Ask a doctor
Storage And Handling
Other information
- some users may experience a brief tingling sensation
- store between 15°-25°C (59°-77°F)
Inactive Ingredient
Inactive ingredients benzalkonium chloride, boric acid, disodium edetate hydrate, purified water, sodium chloride, sodium citrate
Dosage & Administration
Distributed By:
Fred's Inc.
4300 New Getwell Rd.
Memphis, TN 38118
Made in Korea
Package Label.Principal Display Panel
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