Label: ALA-SCALP- hydrocortisone lotion

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 22, 2020

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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 is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11Β)-.  Its structural formula is:

    image description

    Each mL of ALA-SCALP (Hydrocortisone Lotion USP), 2% contains 20 mg of hydrocortisone USP in a vehicle of isopropyl alcohol, polysorbate 20, purified water, propylene glycol, and benzalkonium chloride.

  • CLINICAL PHARMACOLOGY

    Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.  The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear.  Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.  There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

    Pharmacokinetics

    The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.  Topical corticosteroids can be absorbed from normal intact skin.  Inflammation and/or other disease processes in the skin increase percutaneous absorption.  Occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.  (See DOSAGE AND ADMINISTRATION).

    Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.  Corticosteroids are bound to plasma proteins in varying degrees.  Corticosteroids are metabolized primaily in the liver and are then excreted by the kidneys.  Some of the topical corticosteroids and their matabolites are also excreted into the bile.

  • 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 glucosuria in some patients.

    Conditions which augment system absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

    Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.  If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

    Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.  Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

    Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-Pediatric Use).

    If irritation develps, topical corticosteroids should be discontinued and appropriate therapy instituted.

    In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.  If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

    Information for the Patient

    Patients using topical corticosteroids should receive the following information and instructions:

    1. This medication is to be used as directed by the physician.  It is for external use only.  Avoid contact with the eyes.
    2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
    3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
    4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
    5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as the garments may constitute occlusive dressings.

    Laboratory Tests

    The following tests may be helpful in evaluating the HPA axis suppression:

    Urinary free corticol test

    ACTH stimulation test

    Carcinogensis, Mutagenesis, and Impairment of Fertility

    Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

    Studies to determine mutagencity with prednisolone and hydrocortisone have revealed negative results.

    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.

    Nursing Mothers

    It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.  Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.  Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

    Pediatric Use

    Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

    Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.  Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.  Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilaterial papilledema.

    Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen.  Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

  • 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 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/

  • 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 management of psoriasis or recalcitrant conditions.  If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

  • HOW SUPPLIED

    ALA-SCALP (Hydrocortisone Lotion USP) 2% is supplied in:

    2 fl oz (59.2 mL) NDC 77052-010-02

  • STORAGE

    Store at 20 º to 25 ºC (68 º to 77 ºF) [see USP Controlled Room Temperature].

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Derm Ventures LLC

    Petal, MS  39465

    Printed in USA

    REVISED: June 2020

    P8003.04

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALA-SCALP 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:77052-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77052-010-021 in 1 BOX07/24/2020
    159.2 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08323107/24/2020
    Labeler - Derm Ventures LLC (117506566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(77052-010)