Elocon

Elocon is a prescription medicine used on the skin (topically) to relieve redness, swelling, heat, pain (inflammation), and itching caused by certain skin problems. It is available as an ointment, a cream, and a lotion, all containing 0.1% mometasone furoate.

Important information: Elocon is for use on skin only (topical). Do not use Elocon in your eyes, mouth, or vagina.

Elocon ointment and cream

• Elocon ointment and Elocon cream are for use in adults and children 2 years of age or older.
• Not recommended for children under 2 years of age (safety and effectiveness not established).

Elocon lotion

• Elocon lotion is for use in people 12 years of age and older.
• Not recommended for children under 12 years of age (safety and effectiveness not established).

Elocon contains mometasone furoate, a synthetic (man-made) corticosteroid with anti-inflammatory activity. All three formulations are classified as medium-potency topical corticosteroids.

Corticosteroids like mometasone play a role in cellular signaling, immune function, inflammation, and protein regulation, although the exact way they work in skin conditions is not fully understood. When applied to the skin, Elocon is thought to work by dampening the local immune response and reducing the release of chemicals in the skin that cause inflammation. This helps relieve the redness, swelling, heat, and itching associated with corticosteroid-responsive skin conditions.

Only a small amount of Elocon passes into the bloodstream. Studies show that about 0.7% of the applied dose of the ointment and about 0.4% of the applied dose of the cream is absorbed after 8 hours of contact with normal, unbroken skin. A similarly small degree of absorption is expected with the lotion. Absorption may increase if the skin is inflamed or damaged.

Elocon belongs to the drug class called topical corticosteroids.

Do not use Elocon if you are allergic to mometasone furoate or any of the ingredients in your Elocon product. See the end of this leaflet for a complete list of ingredients in each formulation.

Before using Elocon, tell your healthcare provider about all your medical conditions, including if you:

• have had irritation or other skin reaction to a steroid medicine in the past
• have a skin infection at the site to be treated. You may need medicine to treat the skin infection before using Elocon
• have thinning of the skin (atrophy) at the treatment site
• have diabetes
• have adrenal gland problems
• have liver problems
• are pregnant or plan to become pregnant. It is not known if Elocon will harm your unborn baby. If you use Elocon during pregnancy, use it on the smallest area of the skin and for the shortest time needed
• are breastfeeding or plan to breastfeed. It is not known if Elocon passes into your breast milk. If you use Elocon and breastfeed, use it on the smallest area of skin and for the shortest time needed. Do not apply Elocon directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. Do not use other products containing a corticosteroid medicine while using Elocon without talking to your healthcare provider first.

Elocon may cause serious side effects, including:

• Elocon can pass through your skin. Too much Elocon passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems.
• Cushing's syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol.
• High blood sugar (hyperglycemia).
• Effects on growth and weight in children.
• Vision problems. Topical corticosteroids, including Elocon, may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Elocon.
• Skin problems. Skin problems may happen during treatment with Elocon, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using Elocon and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with Elocon.

Common side effects

Elocon ointment

The most common side effects of Elocon ointment are burning, itching, thinning of the skin (atrophy), tingling, stinging, and boils.

Elocon cream

The most common side effects of Elocon cream are burning, itching, and thinning of the skin (atrophy).

Elocon lotion

The most common side effects of Elocon lotion are burning, itching, and inflammation of the hair follicle (folliculitis).

Notes

These are not all the possible side effects of Elocon.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Use Elocon exactly as your healthcare provider tells you to use it.
• Use Elocon until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment.
• Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.
• Elocon should not be used to treat diaper rash or redness. Do not apply Elocon in the diaper area if wearing diapers or plastic pants.
• Avoid using Elocon on the face, groin, or underarms (armpits).
• Wash your hands after applying Elocon.

How to apply the ointment or cream

• Apply a thin film of Elocon ointment or cream to the affected skin area 1 time each day.

How to apply the lotion

• Apply a few drops of Elocon lotion to the affected skin area 1 time each day and rub it in lightly until it disappears.

• Store Elocon at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep Elocon and all medicines out of the reach of children.

Active ingredient (all formulations): mometasone furoate 0.1% (1 mg per gram)

Inactive ingredients in the ointment

Hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum.

Inactive ingredients in the cream

Aluminum starch octenylsuccinate (gamma irradiated), hexylene glycol, hydrogenated soybean lecithin, phosphoric acid, purified water, titanium dioxide, white soft paraffin, and white wax.

Inactive ingredients in the lotion

Hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water, and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5.

Elocon ointment and cream: Distributed by Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA.

Elocon lotion: Distributed by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co. Inc., Whitehouse station, NJ 08889, USA.