Ala-Scalp

Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Hydrocortisone Lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Rx Only For external use only Not for opthalmic use

Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage lavels. 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 prenant patients, in large amounts, or for prolonged periods of time.

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 aproximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermitis, allergic contact dermatis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact Derm Ventures, LLC at 1-833-972-1100 or FDA at 1-800-FDA-1088 or https://fda.gov/Safety/MedWatch/