Label: HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE-

  • NDC Code(s): 42192-118-07
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 09/14

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  • DESCRIPTION

    DESCRIPTION: Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream is a topical preparation containing Hydrocortisone Acetate 2.5% w/w and Pramoxine HCI 1 % w/w in a hydrophilic base containing purified water, cetostearyl alcohol, mineral oil, white petrolatum, propylparaben, triethanolamine laurel sulfate, citric acid, sodium citrate, isopropyl palmitate, stearic acid, lanolin alcohol, methyl paraben, potassium sorbate, sorbic acid, PEG-40 stearate and ceresin wax. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.

    Hcacetate Formula

    Pramoxine Formula

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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

    The mechanism of anti-inflammatory activity of 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.

    Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

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  • PHARMACOKINETICS

    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

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

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  • CONTRAINDICATIONS

    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

    PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (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 and 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

    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 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 dressings.
    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

    Laboratory Tests: Urinary free cortisol test and ACTH stimulation test may be helpful in evaluating the HPA axis suppression.

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  • CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

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

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  • PREGNANCY

    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

    Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts 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.

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  • PEDIATRIC USE

    Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroids induced HPA axis suppression and Cushing’s syndrome than mature patients because of 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 children 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 children 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

    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 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, miliaria.

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  • OVERDOSAGE

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

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three 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.

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  • HOW SUPPLIED:

    Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream
    1 ounce tube (NDC 42192-107-01) 30 x 4 gram tubes (NDC 42192-108-04)

    Hydrocortisone Acetate 2.5%-Pramoxine HCI 1 % Cream Kit with Pramoxine Wipes
    1 ounce tube (NDC 42192-118-07) 30 x 4 gram tubes (NDC 42192-119-30)

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  • STORAGE AND HANDLING

    Storage Conditions: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

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  • SPL UNCLASSIFIED SECTION

    All prescription substitutions and / or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his / her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein."

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  • SPL UNCLASSIFIED SECTION

    Manufactured For:
    Acella Pharmaceuticals, LLC • Alpharetta, GA 30022

    Rev. 0513

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  • PRINCIPAL DISPLAY PANEL - Kit

    NDC 42192-118-07

    Hydrocortisone Acetate 2.5% -
    Pramoxine HCl 1% Cream Kit

    Packaged together for convenience

    Hydrocortisone Acetate 2.5% - Pramoxine HCl 1% Cream
    and
    Pramoxine HCl 1% Wipes

    Rx Only

    Contents: Hydrocortisone Acetate 2.5% - Pramoxine HCl 1% Cream
    Net Wt. 1 oz. tube and applicator
    6 Pramoxine HCl 1% Pre-moistened Anorectal Wipes

    CONTENTS NOT FOR INDIVIDUAL SALE

    Acella
    PHARMACEUTICALS, LLC

    1 tube and 6 wipes

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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE 
    hydrocortisone acetate and pramoxine hydrochloride kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-118
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42192-118-07 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE, WITH APPLICATOR 28 g
    Part 2 1 PACKAGE, COMBINATION 1 g
    Part 1 of 2
    HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE 
    hydrocortisone acetate and pramoxine hydrochloride cream
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 2.5 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CETOSTEARYL ALCOHOL  
    MINERAL OIL  
    PETROLATUM  
    PROPYLPARABEN  
    TRIETHANOLAMINE LAURYL SULFATE  
    CITRIC ACID MONOHYDRATE  
    SODIUM CITRATE  
    ISOPROPYL PALMITATE  
    STEARIC ACID  
    LANOLIN ALCOHOLS  
    METHYLPARABEN  
    POTASSIUM SORBATE  
    SORBIC ACID  
    PEG-40 STEARATE  
    CERESIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 28 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 02/01/2010
    Part 2 of 2
    INERT 
    inert swab
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    WATER  
    CITRIC ACID MONOHYDRATE  
    SODIUM CITRATE  
    POTASSIUM SORBATE  
    PHENOXYETHANOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 g in 1 PACKAGE, COMBINATION
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 02/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 02/01/2010
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Acella Pharmaceuticals, LLC (825380939)
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