Ciclopirox Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. It is not known if Ciclopirox Shampoo is safe and effective in children under 16 years of age.

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

Wet hair and apply approximately 1 teaspoon (5 mL) of LOPROX Shampoo 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.

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

How should I use Ciclopirox Shampoo?

• Use Ciclopirox Shampoo exactly as your doctor tells you to use it.

• Wash your hair using Ciclopirox Shampoo 2 times each week. There should be at least 3 days between each time you use Ciclopirox Shampoo.

• Use Ciclopirox Shampoo for 4 weeks even if your skin condition improves.

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

• Do not swallow Ciclopirox Shampoo.

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

How should I apply Ciclopirox Shampoo?

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

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

Local Effects

If a reaction suggesting sensitivity or irritation occurs with the use of Ciclopirox Shampoo, treatment should be discontinued and appropriate therapy instituted.

Contact of Ciclopirox Shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water.

In patients with lighter hair color, hair discoloration has been reported.

Adverse Reactions

*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 clinical practice.

In 626 subjects treated with Ciclopirox Shampoo twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1% of subjects.

Wash your hair using Ciclopirox Shampoo 2 times each week. There should be at least 3 days between each time you use Ciclopirox Shampoo.

The most common side effects of Ciclopirox Shampoo 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. 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.

Ciclopirox Shampoo 1% is colorless and translucent, and supplied in 120 mL plastic bottle.

Discard unused product after treatment duration.

Store between 15°C and 30°C (59°F and 86°F).

Keep out of reach of children.

We also prescribe the follow medication for dandruff:

• Ketoconazole Shampoo (Generic Nizoral®)