This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.

This shampoo comes with a capsule of medication that the pharmacist must add to the shampoo before giving you this product. Once prepared, shake well before each use. Apply about one ounce of the shampoo to the scalp once daily by working into a lather. Allow it to remain on the scalp for 5 minutes. Then thoroughly rinse your scalp and hair two times. Also rinse any other body parts (such as hands, face, neck, shoulders) that may have come in contact with the shampoo.

Do not bandage, wrap or cover the affected area (such as avoid using shower caps or bathing caps) unless directed by your doctor.

This shampoo should be used only on the scalp. Do not apply this medication to your face, neck, groin, or underarms. After applying the medication, wash your hands. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.

Do not use this medication more often or for a longer period than prescribed because the risk of side effects may be increased. Tell your doctor if your condition lasts or gets worse after 2 weeks.

Burning, stinging, irritation, dryness, or redness may occur when this medication is first applied to the scalp. Acne, excessive hair growth, small red bumps on the skin (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone, triamcinolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other skin/scalp conditions (such as rosacea, perioral dermatitis)

Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when using this medication. Notify your doctor if redness, swelling or irritation does not improve.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Avoid freezing. Keep all medications away from children and pets. Discard after 2 months.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.