Indications
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Pregnancy and breastfeeding
Pregnancy: Teratogenic Effects: Pregnancy Category C – Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time
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 Miliaria
Composition
- Active ingredients
- HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
At a glance
- Brand name
- Pramosone
- Active substance
- hydrocortisone acetate
- Route
- Topical
- Dosage form
- Cream
- Applicant
- Legacy Pharma
- Status
- Prescription
- FDA approval
- 7 Jan 1977
- Application
- ANDA085368-001



