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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- Official Label (Printer Friendly)
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WARNINGS AND PRECAUTIONSRx Only - For external use only - Not for opthalmic use
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DESCRIPTIONTopical corticosteroids constitute a class of primarily synthetic steroids used a anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone ...
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CLINICAL PHARMACOLOGYTopical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various ...
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INDICATIONS AND USAGEHydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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CONTRAINDICATIONSHydrocortisone Lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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PRECAUTIONSGeneral - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia, and ...
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ADVERSE REACTIONSThe 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 ...
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OVERDOSAGETopically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See - PRECAUTIONS).
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DOSAGE AND ADMINISTRATIONTopical 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 ...
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HOW SUPPLIEDHydrocortisone 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
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STORAGEStore at 20 - º to 25 - ºC (68 - º to 77 - ºF) [see USP Controlled Room Temperature].
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PRINCIPAL DISPLAY PANELManufactured for: Allegis Holdings, LLC - Canton MS 39046 - Printed in USA - Rev 05/2024
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INGREDIENTS AND APPEARANCEProduct Information