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.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
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.
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).
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Rev. A 7/2020
NDC 0472-0381 -15
Betamethasone Dipropionate Ointment, USP 0.05%
For Dermatologic Use Only
Not for Ophthalmic Use
15 g (0.53 oz)
| BETAMETHASONE DIPROPIONATE |
betamethasone dipropionate ointment
|Labeler — Actavis Pharma, Inc. (119723554)|
Revised: 08/2020 Actavis Pharma, Inc.
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