Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.

Ciclopirox Shampoo, 1% is not for ophthalmic, oral, or intravaginal use.

Wet hair and apply approximately 1 teaspoon (5 mL) of Ciclopirox Shampoo, 1% to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications.

If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with Ciclopirox Shampoo, 1%, the diagnosis should be reviewed.

Ciclopirox Shampoo, 1% is a shampoo containing 1% ciclopirox.

Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a colorless and translucent shampoo base.

None.

Ciclopirox Shampoo, 1% contains the synthetic antifungal agent, ciclopirox for topical use.

Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate.

Ciclopirox Shampoo, 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

In two randomized, double-blind clinical trials, subjects 16 years and older with seborrheic dermatitis of the scalp applied ciclopirox shampoo, 1% or its vehicle twice weekly for 4 weeks. Subjects who were immunocompromised, those with psoriasis or atopic dermatitis, women of childbearing potential not using adequate contraception, and pregnant or lactating women were excluded from the clinical trials. An evaluation of the overall status of the seborrheic dermatitis, the presence and severity of erythema or inflammation, and scaling, was made at week 4, using a scale of 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = pronounced, and 5 = severe. Effective treatment was defined as achieving a score of 0 (or a score of 1 if the baseline score was ≥ 3) simultaneously for status of the seborrheic dermatitis, erythema or inflammation, and scaling at Week 4. Ciclopirox shampoo was shown to be statistically significantly more effective than vehicle in both trials. Efficacy results for the two trials are presented in Table 1 below.

Table 1. Effective Treatment Rates at Week 4 in Trials 1 and 2

Efficacy for African American subjects was not demonstrated, although only 53 African American subjects were enrolled in the two pivotal trials.

Ciclopirox Shampoo, 1% is colorless and translucent, and supplied in 120 mL plastic bottles (NDC 45802-401-09).

Discard unused product after initial treatment duration.

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

See FDA-approved patient labeling (Patient Information).

The patient should be instructed to:

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Use Ciclopirox Shampoo, 1% as directed by the physician. Avoid contact with the eyes. If contact occurs, rinse thoroughly with water. Ciclopirox Shampoo, 1% is for external use on the scalp only. Do not swallow.

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Use Ciclopirox Shampoo, 1% for seborrheic dermatitis for the full treatment time even though symptoms may have improved. Notify the physician if there is no improvement after 4 weeks.

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Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).

Ciclopirox (sigh-kloe-peer-ox) Shampoo, 1%

What is Ciclopirox Shampoo, 1%?

Ciclopirox Shampoo, 1% is a prescription medicine used on the scalp to treat adults with a skin condition called seborrheic dermatitis.

It is not known if Ciclopirox Shampoo, 1% is safe and effective in children under 16 years of age.

What should I tell my doctor before using Ciclopirox Shampoo, 1%?

Before using Ciclopirox Shampoo, 1%, tell your doctor if you:

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have any other medical conditions

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are pregnant or plan to become pregnant. It is not known if Ciclopirox Shampoo, 1% will harm your unborn baby.

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are breastfeeding or plan to breastfeed. It is not known if ciclopirox passes into your breast milk.

•

are taking prescription and non-prescription medicines, vitamins, and herbal supplements.

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

How should I use Ciclopirox Shampoo, 1%?

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Use Ciclopirox Shampoo, 1% exactly as your doctor tells you to use it.

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Wash your hair using Ciclopirox Shampoo, 1% 2 times each week for 4 weeks. There should be at least 3 days between each time you use Ciclopirox Shampoo, 1%.

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Use Ciclopirox Shampoo, 1% for 4 weeks even if your skin condition improves.

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Tell your doctor if your scalp condition is not getting better after you have used Ciclopirox Shampoo, 1% for 4 weeks.

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Do not swallow Ciclopirox Shampoo, 1%.

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Avoid getting Ciclopirox Shampoo, 1% in your eyes. If Ciclopirox Shampoo, 1% gets into your eyes, rinse them well with water.

How should I apply Ciclopirox Shampoo, 1%?

•

Wet your hair and apply approximately 1 teaspoon of Ciclopirox Shampoo, 1% to your scalp. You may use up to 2 teaspoons of Ciclopirox Shampoo, 1% if you have long hair. Lather and leave Ciclopirox Shampoo, 1% on your hair and scalp for 3 minutes. You may use a timer.

•

After 3 minutes have passed, rinse your hair and scalp.

What are the possible side effects of Ciclopirox Shampoo, 1%?

The most common side effects of Ciclopirox Shampoo, 1% include: itching, burning, and redness of the scalp. Tell your doctor if you get any of these symptoms and they become worse or do not go away, or if you get blistering, swelling, or oozing in your scalp.

These are not all the possible side effects of Ciclopirox Shampoo, 1%. For more information, ask your doctor.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

How should I store Ciclopirox Shampoo, 1%?

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Store Ciclopirox Shampoo, 1% at room temperature, between 20-25°C (68-77°F).

•

Safely throw away any unused Ciclopirox Shampoo, 1% after you finish your treatment.

Keep Ciclopirox Shampoo, 1% and all medicines out of the reach of children.

General information about Ciclopirox Shampoo, 1%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ciclopirox Shampoo, 1% for a condition for which it was not prescribed. Do not give Ciclopirox Shampoo, 1% to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about Ciclopirox Shampoo, 1% that is written for health professionals.

For more information about Ciclopirox Shampoo, 1% call 1-866-634-9120.

What are the ingredients in Ciclopirox Shampoo, 1%?

Active ingredient: ciclopirox

Inactive ingredients: disodium laureth sulfosuccinate,

laureth-2, purified water, sodium chloride, and sodium laureth sulfate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by Padagis®, Yeruham, Israel

www.padagis.com

Rev 03-23

62X6M RC F4

NDC 45802-401-09

Rx Only

Ciclopirox Shampoo, 1%

For Topical Use Only

Not for Ophthalmic, Oral, or Intravaginal Use

Keep Out of Reach of Children

120 mL