Desoximetasone Oint 0.05% (Page 2 of 2)

ADVERSE REACTIONS

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, 0.05% to the affected skin areas twice daily. Rub in gently.

HOW SUPPLIED

Desoximetasone Ointment USP, 0.05% is supplied in the following tube sizes:

60 gram tube (NDC 70512-037-60) 100 gram tube (NDC 70512-037-10)

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 for:

SOLA Pharmaceuticals Baton Rouge, LA 70810

C101325

PI-037-01

Rev 11/2019

PRINCIPAL DISPLAY PANEL

NDC 70512-037-60

Desoximetasone

Ointment USP 0.05%

For Topical Use Only

Not For Oral, Opthalmic or Intravaginal Use

Net Wt. 60 grams

Rx Only

Desoximetasone 60gm Tube
(click image for full-size original)
Desoximetasone Carton 60gm
(click image for full-size original)

NDC 70512-037-10

Desoximetasone

Ointment USP 0.05%

For Topical Use Only

Not For Oral, Opthalmic or Intravaginal Use

Net Wt. 100 grams

Rx Only

Desoximetasone 100gm Tube
(click image for full-size original)
Desoxiemtasone 100gm Carton
(click image for full-size original)

DESOXIMETASONE OINT 0.05%
desoximetasone oint 0.05% ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70512-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESOXIMETASONE (DESOXIMETASONE) DESOXIMETASONE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Product Characteristics
Color white ((off-white)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70512-037-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (70512-037-60)
2 NDC:70512-037-10 1 TUBE in 1 CARTON contains a TUBE
2 100 g in 1 TUBE This package is contained within the CARTON (70512-037-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209973 04/22/2020
Labeler — SOLA Pharmaceuticals (080121345)

Revised: 04/2020 SOLA Pharmaceuticals

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