Desoximetasone (Page 2 of 2)

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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

In controlled clinical studies the incidence of adverse reactions was low (0.3%) for desoximetasone ointment USP, 0.25% and included mild burning sensation at the site of application.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Apply a thin film of desoximetasone ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.

HOW SUPPLIED

Desoximetasone Ointment USP, 0.25% is supplied in 15 gram (NDC 40032-024-61) and 60 gram (NDC 40032-024-60) tubes.

Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

Manufactured by:

Novel Laboratories, Inc

Somerset, NJ 08873

PI0240000101

Iss. 10/2015

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 g Tube carton

NDC 40032-024-61

DESOXIMETASONE desoximetasone ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-024 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESOXIMETASONE (DESOXIMETASONE) DESOXIMETASONE 2.5 mg in 1 g

Inactive Ingredients Ingredient Name Strength COCONUT OIL PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:40032-024-60 1 TUBE in 1 CARTON contains a TUBE 1 60 g in 1 TUBE This package is contained within the CARTON (40032-024-60) 2 NDC:40032-024-61 1 TUBE in 1 CARTON contains a TUBE 2 15 g in 1 TUBE This package is contained within the CARTON (40032-024-61)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206792 05/10/2016

Labeler — Novel Laboratories, Inc. (793518643)

Registrant — Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, Inc.		793518643	analysis (40032-024), manufacture (40032-024)

Revised: 06/2016 Novel Laboratories, Inc.