Label: HYDROCORTISONE- hydrocortisone lotion lotion

  • NDC Code(s): 71297-010-01, 71297-010-02
  • Packager: Allegis Holdings LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 5, 2024

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  • WARNINGS AND PRECAUTIONS
    Rx Only - For external use only - Not for opthalmic use
  • DESCRIPTION
    Topical corticosteroids constitute a class of primarily synthetic steroids used a anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone ...
  • CLINICAL PHARMACOLOGY
    Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various ...
  • INDICATIONS AND USAGE
    Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
  • CONTRAINDICATIONS
    Hydrocortisone Lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
  • PRECAUTIONS
    General - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia, and ...
  • 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 ...
  • OVERDOSAGE
    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See - PRECAUTIONS).
  • DOSAGE AND ADMINISTRATION
    Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the ...
  • HOW SUPPLIED
    Hydrocortisone Lotion USP, 2% is supplied in: 1 fl oz (29.6 mL) NDC 71297-010-01 - 2 fl oz (59.2 mL) NDC 71297-010-02
  • STORAGE
    Store at 20 - º to 25 - ºC (68 - º to 77 - ºF) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL
    Manufactured for: Allegis Holdings, LLC - Canton MS 39046 - Printed in USA - Rev 05/2024
  • INGREDIENTS AND APPEARANCE
    Product Information