Alclometasone Dipropionate (Page 2 of 2)

ADVERSE REACTIONS:

The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE:

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

DOSAGE AND ADMINISTRATION:

Apply a thin film of alclometasone dipropionate ointment to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Alclometasone dipropionate ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with alclometasone dipropionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED:

Alclometasone dipropionate ointment USP, 0.05% is supplied in

15 gram tube NDC 0168-0264-15
45 gram tube NDC 0168-0264-45
60 gram tube NDC 0168-0264-60

Store between 2° and 30°C (36° and 86°F).

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747

I2264D
R09/12
#77

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G Container

NDC 0168-0264-15

Fougera ®

ALCLOMETASONE
DIPROPIONATE OINTMENT
USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach of children.

NET WT 15 grams

15gramTubeLabel
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G Carton

NDC 0168-0264-15

Fougera ®

Rx only

ALCLOMETASONE
DIPROPIONATE OINTMENT
USP, 0.05%

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach of children.

NET WT 15 grams

carton15g
(click image for full-size original)
ALCLOMETASONE DIPROPIONATE alclometasone dipropionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0264
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCLOMETASONE DIPROPIONATE (ALCLOMETASONE) ALCLOMETASONE DIPROPIONATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
WHITE WAX
PROPYLENE GLYCOL MONOSTEARATE
HEXYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0264-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0168-0264-15)
2 NDC:0168-0264-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0168-0264-45)
3 NDC:0168-0264-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (0168-0264-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076884 07/18/2005
Labeler — E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 09/2020 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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