Fluocinonide (Page 2 of 2)

Adverse Reactions to Fluocinonide

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).

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.

HOW SUPPLIED

Fluocinonide Topical Solution USP, 0.05% is supplied in 60 mL (NDC 71085-006-60) bottles.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F).

Mfd. for: IPG Pharmaceuticals, Inc. Tempe, AZ 85281 Made in Canada
Issued: December, 2016

PPK-8373-0
19
1216-0

PRINCIPAL DISPLAY PANEL — 60 mL Bottle Carton

NDC 71085-006-60
60 mL

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.

IPG

Rx only

PRINCIPAL DISPLAY PANEL -- 60 mL Bottle Carton
(click image for full-size original)
FLUOCINONIDE
fluocinonide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71085-006
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 Multilevel Packaging
1 NDC:71085-006-60 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 60 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (71085-006-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074799 12/31/1996
Labeler — IPG PHARMACEUTICALS, INC. (080441238)

Revised: 03/2017 IPG PHARMACEUTICALS, INC.

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