Label: PROCTOZONE HC- hydrocortisone cream

  • NDC Code(s): 64980-301-30
  • Packager: Rising Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 05/12

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  • DESCRIPTION

    The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

    Topical corticosteroids are anti-inflammatory and anti-pruritic agents.

    Hydrocortisone cream is a member of this class. Hydrocortisone cream contains the synthetic steroid hydrocortisone (Pregn-4-ene -3,20-dione, 11, 17, 21-trihydroxy-, (11ß)-) which has a molecular formula of C21H30O5, a molecular weight of 362.46 and CAS Registry Number 50-23-7.

    chemical structure

    Each gram of the 2.5% cream contains 25 mg of hydrocortisone USP in a cream base of cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax and citric acid solution and sodium citrate solution to adjust pH.

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  • 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 to 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.

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  • 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 substantially increase the percutaneous absorption of topical corticosteroids. Thus, 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 primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

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  • INDICATIONS & USAGE

    Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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  • CONTRAINDICATIONS

    Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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  • PRECAUTIONS
  • General:

    Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.

    Conditions which augment systemic 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.

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

    If irritation develops, 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.

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  • Information for Patients:

    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 these garments may constitute occlusive dressings.
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  • Laboratory Tests:

    The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test; ACTH stimulation test.

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  • Carcinogenesis, Mutagenesis, 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 mutagenicity with prednisolone and hydrocortisone have revealed negative results.

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  • 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.

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  • 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 no/ likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

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  • 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 children 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 bilateral 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 children.

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  • 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 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 and miliaria.

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  • OVERDOSAGE

    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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  • DOSAGE & ADMINISTRATION

    Topical corticosteroids are generally applied to the affected area as a thin film from 2 to 4 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.

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  • HOW SUPPLIED

    Hydrocortisone Cream USP, 2.5%
    20 g (0.7 oz) tube
    30 g (1. 1 oz) tube
    1 lb (453.6 g) jar

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  • Storage and Handling

    Store at controlled room temperature 15°-30° (59°-86°F). Do not freeze.

    1 lb jar - Dispense in tight container as defined in the USP.

    Manufactured by:
    Actavis MidAttantic LLC
    1 877 Kawai Road
    Lincolnton, NC 28092 USA

    FORM NO. 0337        Rev.1/06

    VC2750

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Rising           NDC 64980-301-30

    PROCTOZONE-HC TM 2.5%
    (HYDROCORTISONE CREAM USP 2.5%

    Rx Only
    FOR EXTERNAL USE ONLY
    NOT FOR OPHTHALMIC USE

    30G (1.1 oz)

    Proctozone-HC
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  • INGREDIENTS AND APPEARANCE
    PROCTOZONE  HC
    hydrocortisone cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64980-301
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    GLYCERYL MONOSTEARATE  
    ISOPROPYL MYRISTATE  
    METHYLPARABEN  
    POLYOXYL 40 STEARATE  
    POLYSORBATE 60  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SODIUM CITRATE  
    SORBIC ACID  
    SORBITAN MONOSTEARATE  
    STEARYL ALCOHOL  
    WHITE WAX  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64980-301-30 1 in 1 CARTON
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA089682 05/01/2012
    Labeler - Rising Pharmaceuticals, Inc. (041241766)
    Registrant - Actavis Mid Atlantic LLC (809515898)
    Establishment
    Name Address ID/FEI Business Operations
    Actavis Mid Atlantic LLC 809515898 manufacture
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