Fluocinonide Solution

Name: Fluocinonide Solution

Indications and Usage for Fluocinonide Solution

Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning Hypertrichosis Maceration of the skin
Itching Acneiform eruptions Secondary infection
Irritation Hypopigmentation Skin atrophy
Dryness Perioral dermatitis Striae
Folliculitis Allergic contact dermatitis Miliaria

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Fluocinonide Solution Dosage and Administration

Fluocinonide Topical Solution USP, 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

20 mL

NDC 51672-1273-2

Fluocinonide
Topical Solution
USP, 0.05%

FOR TOPICAL
USE ONLY.
NOT FOR
OPHTHALMIC USE.

Keep this and all
medications out of the
reach of children.

Rx only

TARO

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton - Canada

20 mL

NDC 51672-1273-2

Fluocinonide
Topical Solution
USP, 0.05%

FOR TOPICAL
USE ONLY.
NOT FOR
OPHTHALMIC USE.

Keep this and all
medications out of the
reach of children.

Rx only

TARO

FLUOCINONIDE 
Fluocinonide Solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-1273
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluocinonide (Fluocinonide) Fluocinonide 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
citric acid monohydrate  
alcohol  
diisopropyl adipate  
propylene glycol  
water  
Packaging
# Item Code Package Description
1 NDC:51672-1273-2 1 BOTTLE, PLASTIC in 1 CARTON
1 20 mL in 1 BOTTLE, PLASTIC
2 NDC:51672-1273-4 1 BOTTLE, PLASTIC in 1 CARTON
2 60 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074799 12/31/1996
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-1273)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-1273)
Revised: 01/2016   Taro Pharmaceuticals U.S.A., Inc.
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