CLODAN KIT- clobetasol propionate kit

Clodan Kit by

Drug Labeling and Warnings

Clodan Kit by is a Prescription medication manufactured, distributed, or labeled by Medimetriks Pharmaceuticals, Perrigo Israel, Marketing Advertising Promotions inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    1.1 Indication

    Clodan® (clobetasol propionate) Shampoo, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.

    Patients should be instructed to use Clodan® (clobetasol propionate) Shampoo, 0.05% for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)].

    Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

    1.2 Limitations of Use

    Clodan® (clobetasol propionate) Shampoo, 0.05% should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.

  • 2 DOSAGE AND ADMINISTRATION

    Clodan® (clobetasol propionate) Shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

    Clodan® (clobetasol propionate) Shampoo, 0.05% should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

    The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.

    Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying Clodan® (clobetasol propionate) Shampoo, 0.05%.

    Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

    Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with Clodan® (clobetasol propionate) Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

    Clodan® (clobetasol propionate) Shampoo, 0.05% should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician.

  • 3 DOSAGE FORMS AND STRENGTHS

    Shampoo, 0.05%, w/w. Each gram of Clodan® (clobetasol propionate) Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid.

  • 4 CONTRAINDICATIONS

    None

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Effects on the Endocrine System

    Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

    Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

    The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05% applied once daily for 15 minutes to a dry scalp before lathering and rinsing.

    Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

    An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

    Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

    Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure.

    Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

    5.2 Allergic Contact Dermatitis

    If irritation develops, Clodan® (clobetasol propionate) Shampoo, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing.

    5.3 Concomitant Skin Infections

    In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Clodan® (clobetasol propionate) Shampoo, 0.05% should be discontinued until the infection has been adequately controlled.

    5.4 Local Adverse Reactions with Topical Corticosteroids

    Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

  • 6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    In clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.

    Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.

    Table 1: Summary of Selected Adverse Reactions ≥ 1% by Body System
    Body SystemClobetasol Propionate Shampoo, 0.05%
    N=558    		Vehicle Shampoo
    N=127
    Skin and Appendages49 (8.8%)28 (22.0%)
      Discomfort Skin26 (4.7%)16 (12.6%)
      Pruritus3 (0.5%)9 (7.1%)
    Body As A Whole33 (5.9%)12 (9.4%)
      Headache10 (1.8%)1 (0.8%)

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

    6.2 Postmarketing Experience

    Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of clobetasol propionate shampoo, 0.05%.

    • Endocrine disorders: Cushing's syndrome, Adrenal suppression
    • Eye: Eye pain, Vision blurred, Eye irritation
    • CNS: Dizziness
    • GI: Nausea
    • Skin: Erythema, Skin exfoliation, Rash, Skin irritation, Hair color changes, Allergic contact dermatitis, Pain of skin, Skin tightness
    • Other: Psoriasis (aggravation)
  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic effects: Pregnancy Category C.

    There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol propionate shampoo, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

    Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse.

    Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

    The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat. Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 µg/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal no-observed-effect-level (NOEL) for clobetasol propionate was less than 12.5 µg/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 µg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

    8.3 Nursing Mothers

    Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clodan® (clobetasol propionate) Shampoo, 0.05% is administered to a nursing woman.

    8.4 Pediatric Use

    Use of clobetasol propionate shampoo, 0.05% in patients under 18 years old is not recommended due to potential for HPA axis suppression [see Warnings and Precautions (5.1)]

    The effect of clobetasol propionate shampoo, 0.05% on HPA axis suppression was evaluated in one trial in adolescents 12 to 17 years of age with moderate to severe scalp psoriasis with involvement of at least 25% of the scalp. In this trial, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with clobetasol propionate shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only 1 of the 5 subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.

    No studies have been performed in patients under the age of 12. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. Therefore, use is not recommended in patients under the age of 18.

    HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

    8.5 Geriatric Use

    Clinical studies of clobetasol propionate shampoo, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

  • 10 OVERDOSAGE

    Topically applied, Clodan® (clobetasol propionate) Shampoo, 0.05% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]

  • 11 DESCRIPTION

    Clodan® (clobetasol propionate) Shampoo, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

    The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate.

    It has the following structural formula:

    Chemical Structure

    Clobetasol propionate

    Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32ClFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

    Each gram of Clodan® (clobetasol propionate) Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid shampoo base consisting of alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Like other topical corticosteroids, Clodan® (clobetasol propionate) Shampoo, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

    12.2 Pharmacodynamics

    Vasoconstrictor Assay

    Clodan® (clobetasol propionate) Shampoo, 0.05% is in the super-high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

    Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

    In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, use of clobetasol propionate shampoo, 0.05% resulted in demonstrable HPA axis suppression in 5 out of 12 (42%) adolescent subjects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

    12.3 Pharmacokinetics

    The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.

    Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.

    There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis).

    Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.

    Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.

    The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 µg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 µg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 µg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

  • 14 CLINICAL STUDIES

    The safety and efficacy of clobetasol propionate shampoo, 0.05% have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either clobetasol propionate shampoo, 0.05% or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below.

    Table 2: Efficacy ResultsClobetasol Propionate Shampoo, 0.05%
    N (%)    		Shampoo Vehicle
    N (%)
    Study AStudy BStudy AStudy B
  • * Success rate defined as the proportion of subjects with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician's Global Severity Scale for scalp psoriasis.
  • † At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available).
  • ‡ Subjects with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale.
    		•
    Total Number of Subjects95994749
    Success Rate* at Endpoint†40 (42.1%)28 (28.3%)1 (2.1%)5 (10.2%)
    Subjects with Scalp Psoriasis Parameter Clear (None) at Endpoint
    Erythema‡17 (17.9%)12 (12.1%)3 (6.4%)1 (2.0%)
    Scaling‡21 (22.1%)15 (15.2%)0 (0%)2 (4.1%)
    Plaque Thickening‡35 (36.8%)34 (34.3%)5 (10.6%)5 (10.2%)

    Clinical studies of clobetasol propionate shampoo, 0.05% did not include sufficient numbers of non-Caucasian subjects to determine whether they respond differently than Caucasian subjects with regards to efficacy and safety.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Clodan® (clobetasol propionate) Shampoo, 0.05% is a translucent, colorless viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 43538-950-04

    Storage: Keep bottle tightly closed. Store at USP controlled room temperature 68° to 77°F (20° - 25°C), with excursions permitted between 59° and 86°F (15° - 30°C).

  • 17 PATIENT COUNSELING INFORMATION

    See FDA-approved patient labeling (Patient Information)

    Information for Patients

    Inform the patient using topical corticosteroids to adhere to the following instructions:

    • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
    • Clodan® (clobetasol propionate) Shampoo, 0.05% is for external use only. It should not be used on the face, underarms or groin areas. Avoid contact with the eyes and lips.
    • This medication should not be used for any disorder other than that for which it was prescribed.
    • The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician.
    • Patients should report any signs of local or systemic adverse reactions to their physician.
    • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
    • Patients should wash their hands after applying the medication.
    • Patients should inform their physician(s) that they are using Clodan® (clobetasol propionate) Shampoo, 0.05% if surgery is contemplated.
    • Do not use other corticosteroid-containing products while using Clodan® (clobetasol propionate) Shampoo, 0.05%.
    • Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of Clodan® (clobetasol propionate) Shampoo, 0.05%.
  • SPL UNCLASSIFIED SECTION

    Manufactured for: Medimetriks Pharmaceuticals, Inc.
    383 Route 46 West, Fairfield, NJ 07004-2402 www.medimetriks.com

    Manufactured by: Perrigo, Yeruham, Israel

    Made in Israel

    Rev. 02/2016
    IP035-R1
    6A900 EK J1

  • Patient Information

    Clodan® (clobetasol propionate) Shampoo, 0.05%

    Important: For use on the scalp only. Do not get Clodan® (clobetasol propionate) Shampoo, 0.05% near or in your eyes, mouth or vagina.

    Read the Patient Information that comes with Clodan® (clobetasol propionate) Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

    What is Clodan® (clobetasol propionate) Shampoo, 0.05%?

    • Clodan® Shampoo is a prescription corticosteroid medicine used to treat adults with moderate to severe forms of scalp psoriasis. Clodan® Shampoo is for use on the scalp only (topical).
    • Clodan® Shampoo should be used for the shortest amount of time needed to treat your scalp psoriasis.
    • You should not use Clodan® Shampoo for longer than 4 weeks in a row.
    • You should not use more than 50 mL (1.75 fluid ounces) of Clodan® Shampoo in one week.

    You should not use Clodan® (clobetasol propionate) Shampoo, 0.05%:

    • on your face, underarms (armpits) or groin areas. Avoid getting Clodan® Shampoo in your eyes or on your lips.
      Clodan® Shampoo should not be used in children under 18 years of age.

    What should I tell my doctor before using Clodan® (clobetasol propionate) Shampoo, 0.05%?

    Before you use Clodan® Shampoo, tell your doctor if you:

    • have a scalp infection. You may need medicine to treat the scalp infection before you use Clodan® Shampoo.
    • have any open sores or cuts on your scalp
    • plan to have surgery
    • have acne vulgaris, rosacea, or a rash around your mouth (perioral dermatitis)
    • have any other medical conditions
    • are pregnant or plan to become pregnant. It is not known if Clodan® Shampoo can harm your unborn baby.
    • are breast-feeding or plan to breast-feed. It is not known if Clodan® Shampoo passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Clodan® Shampoo.

    Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using Clodan® Shampoo. Ask your doctor or pharmacist if you are not sure.

    Know the medicines you take. Keep a list of them to show your doctor and pharmacist if you get a new medicine.

    How should I use Clodan® (clobetasol propionate) Shampoo, 0.05%?

    • Use Clodan® Shampoo exactly as your doctor tells you to use it.
    • Your doctor should tell you how much Clodan® Shampoo to use and where to apply it.
    • Clodan® Shampoo is for use on your scalp only (topical).
    • Apply Clodan® Shampoo on affected areas of your scalp one time each day.
    • Use only enough Clodan® Shampoo to cover the affected areas of your scalp.
    • Do not use Clodan® Shampoo on your face, groin, or underarms. Avoid getting Clodan® in your eyes or on your lips.
    • Do not wet your hair before using Clodan® Shampoo.
    • If Clodan® Shampoo gets on any part of your body other than your scalp, rinse the area well with water.
    • You should not bandage or cover your head with a shower cap, bathing cap, or a towel, while Clodan® Shampoo is on your scalp, unless your doctor tells you to.
    • Tell your doctor if your scalp condition is not getting better after 4 weeks of using Clodan® Shampoo. You should not use Clodan® Shampoo for more than 4 weeks unless your doctor tells you to.

    See the "Instructions for Use" at the end of the Patient Information for detailed information about the right way to use Clodan® Shampoo.

    What are the possible side effects of Clodan® (clobetasol propionate) Shampoo, 0.05%?

    Clodan® Shampoo can pass through your skin. Too much Clodan® Shampoo passing through your skin can cause your adrenal glands to stop working.

    Your doctor may do blood tests to check how well your adrenal glands are working.

    The most common side effects of Clodan® (clobetasol propionate) Shampoo, 0.05% include:

    • burning or stinging at the site of application
    • itching
    • swelling
    • inflamed hair follicle
    • acne
    • dry, itchy and reddened skin
    • hair loss
    • rash or hives
    • thinning of the skin
    • widening of small blood vessels in the skin

    If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clodan® Shampoo.

    Tell your doctor if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of Clodan® (clobetasol propionate) Shampoo, 0.05%. For more information, ask your doctor or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    You may also report side effects to Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512.

    How should I store Clodan® (clobetasol propionate) Shampoo, 0.05%?

    • Store Clodan® Shampoo at room temperature between 68°F to 77°F (20°C to 25°C).
    • Keep the Clodan® Shampoo bottle tightly closed.

    Keep Clodan® Shampoo and all medicines out of the reach of children.

    General information about Clodan® (clobetasol propionate) Shampoo, 0.05%

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clodan® Shampoo for a condition for which it was not prescribed. Do not give Clodan® Shampoo to other people, even if they have the same symptoms that you have. It may harm them.

    This Patient Information leaflet summarizes the most important information about Clodan® Shampoo. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clodan® Shampoo that is written for health professionals.

    What are the ingredients in Clodan® (clobetasol propionate) Shampoo, 0.05%?

    Active ingredient: clobetasol propionate

    Inactive ingredients (shampoo base): alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

  • Instructions for Use

    Clodan® (clobetasol propionate) Shampoo, 0.05%

    Important: For use on the scalp only. Do not get Clodan® (clobetasol propionate) Shampoo, 0.05% near or in your eyes, mouth or vagina.

    Read the Instructions for Use that comes with Clodan® (clobetasol propionate) Shampoo, 0.05% before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

    How to apply Clodan® Shampoo to your scalp:

    Your hair should be dry when you apply Clodan® Shampoo to your scalp.

    Do not get Clodan® Shampoo on your face, in your eyes or on your lips. If Clodan® Shampoo does get on these areas, rinse well with water.

    Step 1: To apply Clodan® Shampoo to your scalp, part your hair at the area where it is to be applied.

    Step 2: Hold the bottle of Clodan® Shampoo over the affected area. Gently squeeze the bottle and apply a small amount of shampoo to the affected area.

    Step 3: Gently rub Clodan® Shampoo into the affected area so that only the affected area is covered with a thin, even layer of Clodan® Shampoo.

    Step 4: Repeat Steps 1 through 3 to apply Clodan® Shampoo to other affected areas on your scalp as instructed by your doctor.

    Step 5: Wash your hands after applying Clodan® Shampoo.

    Step 6: Leave Clodan® Shampoo on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel while Clodan® Shampoo is on your scalp, unless your doctor tells you to.

    Step 7: After 15 minutes have passed, wet your hair with water. Lather and rinse your hair and scalp completely. Rinse any other parts of your body that come into contact with Clodan® Shampoo, such as your hands, face, neck and shoulders.

    No other shampoo is needed, but you may wash your hair with a non-medicated shampoo after using Clodan® Shampoo.

    This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

    Manufactured for: Medimetriks Pharmaceuticals, Inc.
    383 Route 46 West, Fairfield, NJ 07004-2402 www.medimetriks.com

    Manufactured by: Perrigo, Yeruham, Israel

    Made in Israel

    Rev. 02/2016
    IP035-R1
    6A900 EK J1

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC: 43538-951-04

    Rx Only
    Clodan® KIT
    (clobetasol propionate) Shampoo, 0.05%

    For External Use Only
    Do Not Use in Eyes

    KIT CONTENTS:
    1 - Clodan® (clobetasol propionate) Shampoo, 0.05% - 4 fl. oz. (118 mL)
    1 - Rehyla® Hair & Body Cleanser - Net wt. 16 oz. (454 g)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLODAN KIT 
    clobetasol propionate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43538-951
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43538-951-041 in 1 CARTON; Type 1: Convenience Kit of Co-Package06/15/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 454 g
    Part 1 of 2
    CLODAN 
    clobetasol propionate shampoo
    Product Information
    Item Code (Source)NDC: 43538-950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    clobetasol propionate (UNII: 779619577M) (clobetasol - UNII:ADN79D536H) clobetasol propionate0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    coco-betaine (UNII: 03DH2IZ3FY)  
    sodium laureth-3 sulfate (UNII: BPV390UAP0)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43538-950-041 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09097406/22/2014
    Part 2 of 2
    REHYLA HAIR AND BODY 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRglyceryl stearate SE (UNII: FCZ5MH785I)  
    INGRglycerin (UNII: PDC6A3C0OX)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRcocamidopropyl betaine (UNII: 5OCF3O11KX)  
    INGRcetyl alcohol (UNII: 936JST6JCN)  
    INGRDISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRSODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRcaprylyl glycol (UNII: 00YIU5438U)  
    INGRphenoxyethanol (UNII: HIE492ZZ3T)  
    INGRsodium chloride (UNII: 451W47IQ8X)  
    INGRpropylene glycol (UNII: 6DC9Q167V3)  
    INGRPEG-8 dimethicone (UNII: GIA7T764OD)  
    INGRhyaluronate sodium (UNII: YSE9PPT4TH)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRsalicylic acid (UNII: O414PZ4LPZ)  
    INGRCHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    INGRLAURETH-12 SUCCINATE (UNII: 8W3F9H704N)  
    INGRC13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    INGRLaureth-7 (UNII: Z95S6G8201)  
    INGRedetate disodium (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1454 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09097406/15/2014
    Labeler - Medimetriks Pharmaceuticals (019903816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Perrigo Israel600093611MANUFACTURE(43538-950)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marketing Advertising Promotions inc079486545PACK(43538-951)
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