Neo-Synalar

What is Neo-Synalar used for?

Neo-Synalar is a prescription medicine that is used to treat certain skin problems when a skin infection is present.

Description:

NEO-SYNALAR® cream is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-, and the antibacterial neomycin sulfate. Fluocinolone acetonide has the following chemical structure:

The cream contains neomycin sulfate 5 mg/g (3.5 mg/g neomycin base) and fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.

Before taking Neo-Synalar, tell your doctor:

• If you are allergic to Neo-Synalar; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are using Neo-Synalar in the ear and you have a ruptured ear drum. Do not use in the ear if you have a ruptured ear drum.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Neo-Synalar with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Neo-Synalar?

• Tell all of your health care providers that you take Neo-Synalar. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not put on cuts, scrapes, or damaged skin.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Do not use longer than you have been told by the doctor.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Neo-Synalar while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Neo-Synalar best taken?

Use Neo-Synalar as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Neo-Synalar by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Do not use tight-fitting diapers or plastic pants if treated part is in the diaper area. This may cause more drug to get into the body.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• To use Neo-Synalar on a hairy area, part the hair so that you can reach the affected skin.
• Use as you have been told, even if your signs get better.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

What are the side effects of Neo-Synalar that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Skin irritation.

What are some other side effects of Neo-Synalar?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Dry skin.
• Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Neo-Synalar?

• Store at room temperature. Do not freeze.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label:

• Rx Only
• NDC 43538-940-60
• NEO-SYNALAR®
  [neomycin sulfate 0.5% (0.35% neomycin base),
  fluocinolone acetonide 0.025%] Cream
• 60 g
• For Topical Use Only
  Not For Ophthalmic Use
• MEDIMETRIKS
  PHARMACEUTICALS, INC.