Fluocinolone Solution

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

STORAGE

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.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PI0690600202

Rev. 06/2017

Package label.principal display panel

Fluocinolone Acetonide Topical Solution, USP 0.01%

For Topical Use Only

Not for Ophthalmic Use

Rx Only

60 mL- Container Label

NDC 43386-069-60

Carton Label

FLUOCINOLONE ACETONIDE 
fluocinolone acetonide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43386-069
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) FLUOCINOLONE ACETONIDE 0.1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
PROPYLENE GLYCOL  
Packaging
# Item Code Package Description
1 NDC:43386-069-60 1 BOTTLE in 1 CARTON
1 60 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206422 09/02/2015
Labeler - Lupin Pharmaceuticals,Inc. (089153071)
Registrant - GAVIS Pharmaceuticals, LLC (829838551)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS(43386-069), MANUFACTURE(43386-069), PACK(43386-069)
Revised: 09/2017   Lupin Pharmaceuticals,Inc.
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