Desoximetasone Gel

Name: Desoximetasone Gel

Indications and Usage for Desoximetasone Gel

Desoximetasone Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Desoximetasone Gel USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

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

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 Gel USP, 0.05% with one subject reporting stinging and burning at the site of application.

How is Desoximetasone Gel Supplied

Desoximetasone Gel USP, 0.05% is supplied in:
15 g tubes (NDC 65179-501-15)
60 g tubes (NDC 65179-501-60)

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

Manufactured By:
Groupe Parima Inc.
4450 Cousens Montreal
Quebec, Canada H4S 1X6

Made in Canada

Revised: 09/2014

DESOXIMETASONE 
Desoximetasone Gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65179-501
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
CARBOMER HOMOPOLYMER TYPE C  
DOCUSATE SODIUM  
EDETATE DISODIUM  
ISOPROPYL MYRISTATE  
WATER  
ALCOHOL  
TROLAMINE  
Packaging
# Item Code Package Description
1 NDC:65179-501-15 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:65179-501-60 1 TUBE in 1 CARTON
2 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204675 08/12/2016
Labeler - GROUPE PARIMA INC (252437850)
Registrant - GROUPE PARIMA INC (252437850)
Establishment
Name Address ID/FEI Operations
GROUPE PARIMA INC 252437850 manufacture(65179-501)
Revised: 08/2016   GROUPE PARIMA INC
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