Label: CLODERM- clocortolone pivalate cream

  • NDC Code(s): 67857-804-23, 67857-804-45, 67857-804-48, 67857-804-51, view more
    67857-804-90
  • Packager: Promius Pharma, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated April 22, 2019

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    FOR TOPICAL DERMATOLOGIC USE ONLY–

    NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

    WARNING: KEEP OUT OF REACH OF CHILDREN

  • DESCRIPTION:

    Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.

    Chemically, clocortolone pivalate is
    9-chloro-6α-fluoro-11β,
    21-dihydroxy-16α methylpregna-1,
    4-diene-3, 20-dione 21-pivalate.
    Its structure is as follows:
    Chemical Structure
  • 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 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.

  • INDICATIONS AND USAGE:

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

  • CONTRAINDICATIONS:

    Topical corticosteroids are 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, 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.

    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 these garments may constitute occlusive dressings.

    Laboratory Tests:

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

    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.

    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.

    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 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 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.

  • 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
  • OVERDOSAGE:

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

  • DOSAGE AND ADMINISTRATION:

    Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.


    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 anti-microbial therapy instituted.

  • HOW SUPPLIED:

    Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 75 gram pump bottles, 45 gram and 90 gram tubes.

    75 gram pump bottleNDC 67857-804-51
    45 gram tubeNDC 67857-804-45
    90 gram tubeNDC 67857-804-90
  • STORAGE:

    Store Cloderm Cream between 15° and 30° C (59° and 86° F). Avoid freezing.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Promius Pharma, LLC
    Princeton, NJ 08540

    Cloderm® is a trademark of Coria Laboratories, LTD.

    Manufactured by:
    DPT LABORATORIES, LTD.
    San Antonio, Texas 78215




    R 0617

  • PRINCIPAL DISPLAY PANEL - 75 gram Pump Bottle Carton

    NDC 67857-804-51
    Rx ONLY
    For Topical Use Only

    Cloderm®
    (clocortolone pivalate)
    Cream, 0.1%

    Pump

    Net Wt 75 g

    PROMIUS®
    PHARMA

    PRINCIPAL DISPLAY PANEL - 75 gram Pump Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 75 gram Pump Bottle Label

    PRINCIPAL DISPLAY PANEL - 75 gram Pump Bottle Label

  • INGREDIENTS AND APPEARANCE
    CLODERM 
    clocortolone pivalate cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67857-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    clocortolone pivalate (UNII: QBL8IZH14X) (clocortolone - UNII:N8ZUB7XE0H) clocortolone pivalate0.001 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67857-804-4545 g in 1 TUBE; Type 0: Not a Combination Product04/01/2011
    2NDC:67857-804-5175 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2011
    3NDC:67857-804-9090 g in 1 TUBE; Type 0: Not a Combination Product04/01/2011
    4NDC:67857-804-4810 in 1 CARTON04/01/2011
    4NDC:67857-804-232 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01776508/22/1977
    Labeler - Promius Pharma, LLC (020408265)
    Registrant - Promius Pharma, LLC (020408265)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories, LTD832224526MANUFACTURE(67857-804)