FDA Label for Freds Dry Eye Relief
View Indications, Usage & Precautions
Freds Dry Eye Relief Product Label
The following document was submitted to the FDA by the labeler of this product Hanlim Pharm. Co., Ltd.. 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
Glycerin 0.2% ....................................................................Lubricant
Polyethylene Glycol 400 1% ...............................................Lubricant
Hypromellose 0.2% ............................................................Lubricant
Otc - Purpose
Uses
- for the temporary relief of burning and irritation due to dryness of the eye
- for protection against further irritation
Warnings
Warnings
For external use only
Otc - When Using
When using this product
- 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 the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
- put 1 to 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 at 15o to 25oC (59o to 77oF)
Inactive Ingredient
Inactive ingredients: ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycine, magnesium chloride, potassium chloride, purified water,
sodium borate, sodium chloride, sodium citrate, and sodium lactate
Dosage & Administration
Distributed by: Fred's Inc.
4300 New Getwell Rd.
Memphis, TN 38118
www.fredsinc.com
Package Label.Principal Display Panel
Enter section text here
* Please review the disclaimer below.