Name: Fluocinolone Solution
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Fluocinolone Solution?
- Store at room temperature. Do not freeze.
- Protect from heat.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Fluocinolone Solution Description
Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure:
Fluocinolone Acetonide Topical Solution USP, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water washable base of citric acid and propylene glycol.
Indications and Usage for Fluocinolone Solution
Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
How is Fluocinolone Solution Supplied
Fluocinolone Acetonide Topical Solution USP, 0.01%
60 cc Bottle with applicator tip – NDC 43386-069-60
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.
Lupin Pharmaceuticals, Inc.
Baltimore, MD 21202
Novel Laboratories, Inc.
Somerset, NJ 08873
Package label.principal display panel
Fluocinolone Acetonide Topical Solution, USP 0.01%
For Topical Use Only
Not for Ophthalmic Use
60 mL- Container Label
|FLUOCINOLONE ACETONIDE |
fluocinolone acetonide solution
|Labeler - Lupin Pharmaceuticals,Inc. (089153071)|
|Registrant - GAVIS Pharmaceuticals, LLC (829838551)|
|Novel Laboratories, Inc.||793518643||ANALYSIS(43386-069), MANUFACTURE(43386-069), PACK(43386-069)|