Fluocinonide (Page 2 of 2)

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Fluocinonide Cream, USP 0.05% (Emulsified Base) is generally applied to the affected area as a thin film from two to four times daily, as needed.

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 Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0713-0664-15), 30 g (NDC 0713-0664-31) and 60 g (NDC 0713-0664-60) tubes.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate.

Distributed by:

Cosette Pharmaceuticals,Inc.

South Plainfield, NJ 07080

VC7673
Rev. 09/2022
8-0664CPLNC3

PRINCIPAL DISPLAY PANEL

NDC 0713-0664-15

Fluocinonide Cream,USP (Emulsified Base) 0.05%

15 g

Rx only

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

15gm-carton
(click image for full-size original)

NDC 0713-0664-31

Fluocinonide Cream,USP (Emulsified Base) 0.05 30 g

Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

30gm-carton
(click image for full-size original)

NDC 0713-0664-60

Fluocinonide Cream,USP (Emulsified Base) 0.05%

60 g Rx only

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

60gm-carton
(click image for full-size original)
FLUOCINONIDE
fluocinonide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0664
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINONIDE (FLUOCINONIDE) FLUOCINONIDE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
ANHYDROUS CITRIC ACID
MINERAL OIL
POLYSORBATE 60
PROPYLENE GLYCOL
WATER
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0664-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0713-0664-15)
2 NDC:0713-0664-31 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (0713-0664-31)
3 NDC:0713-0664-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (0713-0664-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074204 03/21/2016
Labeler — Cosette Pharmaceuticals, Inc. (116918230)
Registrant — Cosette Pharmaceuticals, Inc. (116918230)
Establishment
Name Address ID/FEI Operations
Cosette Pharmaceuticals NC Laboratories, LLC 079419931 analysis (0713-0664), label (0713-0664), manufacture (0713-0664), pack (0713-0664)

Revised: 11/2023 Cosette Pharmaceuticals, Inc.

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