Betamethasone Dipropionate (Page 2 of 2)

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently when betamethasone dipropionate ointment is used as recommended in the DOSAGE AND ADMINISTRATION section. 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, miliaria.

Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate ointment during a pediatric clinical study include signs of skin atrophy (telangiectasia, thinness, shininess, bruising, loss of skin markings). Cutaneous atrophy of the face occurred in 1/6 (17%) of infants, 2/9 (22%) of 2 to 5 year olds, and 2/6 (33%) of the 6 to 8 year olds. Non-facial atrophy occurred in 15%, 8%, and 9% of 2 to 5 year olds, 6 to 8 year olds, and 9 to 12 year olds, respectively. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of 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 betamethasone dipropionate ointment 0. 05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary.

Betamethasone dipropionate ointment is not to be used with occlusive dressings.

HOW SUPPLIED

Betamethasone dipropionate ointment, USP 0. 05% is available in:

  • 15 gram (0. 53 oz) NDC 0472-0381-15
  • 45 gram (1. 59 oz) NDC 0472-0381-45

Store between 15° to 30°C (59° to 86°F).

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 7/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0472-0381 -15

Betamethasone Dipropionate Ointment, USP 0.05%

Rx only

For Dermatologic Use Only

Not for Ophthalmic Use

15 g (0.53 oz)

image
(click image for full-size original)
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0381
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0472-0381-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (0472-0381-15)
2 NDC:0472-0381-45 1 TUBE in 1 CARTON contains a TUBE
2 45 g in 1 TUBE This package is contained within the CARTON (0472-0381-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071012 02/01/1997
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 08/2020 Actavis Pharma, Inc.

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