LINDANE - lindane shampoo, suspension 
Morton Grove Pharmaceuticals, Inc.

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MEDICATION GUIDE

Lindane (LIHN-dane) Shampoo, USP 1%

You must read and follow all instructions before using Lindane Shampoo. Read the information you get every time you or a family member get Lindane Shampoo. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Lindane Shampoo, ask your doctor or pharmacist.

What is the most important information I should know about Lindane Shampoo?

Lindane Shampoo is a poison if you do not use it the right way. Lindane Shampoo goes through your skin and can affect your brain and nerves. Lindane Shampoo can cause seizures, also called convulsions, "fits" or epilepsy.

If you or a family member has a seizure while using Lindane Shampoo, get emergency help right away.

What is Lindane Shampoo?

Lindane Shampoo is a medicine that is used to treat lice. It kills lice and their eggs. Lice are very small bugs that attach to the skin on your head or pubic (crotch) area and lay eggs called nits in your hair. Some people call crotch lice "crabs". Lice can cause severe itching. Lindane Shampoo gets into the lice and the nits and kills them. It also goes through your skin. Lindane Shampoo is used only after safer medicines have not made your lice go away. The only time Lindane Shampoo is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.

Lindane Shampoo is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds use Lindane Shampoo only if your doctor thinks it is really needed. People who weigh less than 110 pounds and the elderly have higher chances for side effects because more Lindane may go through their skin.

Who should not use Lindane Shampoo?

Do not use Lindane Shampoo:

Tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may increase your chances of having a seizure if you take them while using Lindane Shampoo. Especially tell your doctor if you take medicines called sedatives (drugs to help you sleep).

How do I use Lindane Shampoo?

Before you put it on:

When you put it on:

When you are supposed to wash it off:

After you wash off Lindane Shampoo:

You may still itch after you have used Lindane Shampoo. This does not mean you need more Lindane Shampoo. Even after all the lice (bugs) are dead, they can still make your skin itch for a long time. Lindane Shampoo sometimes makes this itch even worse. Talk to your doctor about things you can do to soothe the itch.

What should I avoid while using Lindane Shampoo?

What are the possible side effects of Lindane Shampoo?

Lindane Shampoo may cause serious side effects such as seizures (convulsions, fits) or death (See the section, "What is the most important information I should know about Lindane Shampoo?"). Lindane Shampoo can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.

The most common side effects of Lindane Shampoo are:

These are not all of the possible side effects of Lindane Shampoo. 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.

General Information about Lindane Shampoo:

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Lindane Shampoo for any condition for which it was not prescribed. Do not give Lindane Shampoo to other people, even if they have the same symptoms that you have. It may harm them. Keep Lindane Shampoo and all medicines out of the reach of children.

This Medication Guide summarizes the most important information about Lindane Shampoo. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Lindane Shampoo that is written for health professionals.

What are the ingredients in Lindane Shampoo?

Active Ingredient: Lindane.

Inactive Ingredients: triethanolamine lauryl sulfate, polysorbate 60, hydrochloric acid, acetone and purified water.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Lindane is only available by a prescription from your doctor.

Product No.: 8834

Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

28834A

REV. 07-19

Revised: 12/2020
Morton Grove Pharmaceuticals, Inc.