Patient information: uses, side effects, how to take - Rhofade

What is Oxymetazoline Hydrochloride Cream?

Oxymetazoline Hydrochloride Cream is a prescription medicine used on the skin (topical) to treat facial redness due to rosacea that does not go away (persistent) in adults.

It is not known if Oxymetazoline Hydrochloride Cream is safe and effective in children under 18 years of age.

Before you use Oxymetazoline Hydrochloride Cream, tell your healthcare provider about all of your medical conditions, including if you:

have heart, blood vessel, or blood pressure problems. Call your healthcare provider or get medical help if these conditions worsen.
have problems with blood circulation or have had a stroke
have Sjögren's Syndrome
have scleroderma
have Raynaud's phenomenon
have thromboangitis obliterans
have narrow-angle glaucoma. Call your healthcare provider or get medical help if your glaucoma worsens.
have irritated skin or open sores on the face
are pregnant or plan to become pregnant. It is not known if Oxymetazoline Hydrochloride Cream will harm your unborn baby.
are breastfeeding. It is not known if Oxymetazoline Hydrochloride Cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use Oxymetazoline Hydrochloride Cream.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using Oxymetazoline Hydrochloride Cream with certain other medicines may affect each other and can cause serious side effects.

How should I use OXYMETAZOLINE HYDROCHLORIDE CREAM cream?

See the detailed Instructions for Use that comes with your Oxymetazoline Hydrochloride Cream tube or pump for information about how to apply Oxymetazoline Hydrochloride Cream correctly.
Use Oxymetazoline Hydrochloride Cream exactly as your healthcare provider tells you. Do not use more Oxymetazoline Hydrochloride Cream than prescribed.
Oxymetazoline Hydrochloride Cream is for use on your skin only. Do not use Oxymetazoline Hydrochloride Cream in your eyes, mouth, or vagina. Avoid contact with your lips and eyes.
Do not apply Oxymetazoline Hydrochloride Cream to irritated skin or open wounds.

What are the possible side effects of Oxymetazoline Hydrochloride Cream?

The most common side effects of Oxymetazoline Hydrochloride Cream include application site reactions of:

skin reactions (dermatitis)
worsening of rosacea pimples
itching
redness
pain

These are not all the possible side effects of Oxymetazoline Hydrochloride Cream.

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

How should I store Oxymetazoline Hydrochloride Cream?

Store Oxymetazoline Hydrochloride Cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Oxymetazoline Hydrochloride Cream and all medicines out of the reach of children.

General information about the safe and effective use of Oxymetazoline Hydrochloride Cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Oxymetazoline Hydrochloride Cream for a condition for which it was not prescribed. Do not give Oxymetazoline Hydrochloride Cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Oxymetazoline Hydrochloride Cream that is written for health professionals.

What are the ingredients in Oxymetazoline Hydrochloride Cream?

Active ingredient: oxymetazoline hydrochloride

Inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water

Distributed by:

Mayne Pharma

Raleigh, NC 27609

Patented. U.S. Patent Numbers: U.S. 7,812,049; U.S. 8,420,688; U.S. 8,815,929; U.S. 8,883,838; U.S. 9,974,773 and U.S. 10335391. Product of Germany.

INSTRUCTIONS FOR USE

Oxymetazoline Hydrochloride Cream, 1%

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Important:

Oxymetazoline Hydrochloride Cream is for skin (topical) use on the face only. Do not use Oxymetazoline Hydrochloride Cream in your eyes, mouth, or vagina.
Keep Oxymetazoline Hydrochloride Cream out of the reach of children.
Get medical help right away if you, a child, or anyone else swallows Oxymetazoline Hydrochloride Cream.

Read and follow the steps below so that you use your tube of Oxymetazoline Hydrochloride Cream correctly:

Step 1: Open the tube of Oxymetazoline Hydrochloride Cream by gently pressing down on the child-resistant cap and twisting it counterclockwise until the cap is removed. Do not squeeze the tube while opening or closing.

Note: When the cap is removed, the tube is not child-resistant.

Step 2: To apply Oxymetazoline Hydrochloride Cream to your face, squeeze a pea- sized amount of Oxymetazoline Hydrochloride Cream from the tube onto your fingertip.

Step 3: Apply the pea-sized amount of Oxymetazoline Hydrochloride Cream to cover your entire face (forehead, nose, each cheek, and chin) 1 time each day. Spread the cream smoothly and evenly in a thin layer over your face.

Avoid contact with your eyes and lips.
Do not apply cream to irritated skin or open wounds.

Step 4: To close your Oxymetazoline Hydrochloride Cream tube, place the cap back on the tube. Press down on the child-resistant cap and twist clockwise until it stops. The tube is child-resistant again.

Step 5: Wash your hands right away after applying Oxymetazoline Hydrochloride Cream.

How do I store Oxymetazoline Hydrochloride Cream?

Store Oxymetazoline Hydrochloride Cream cream at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Oxymetazoline Hydrochloride Cream and all medicines out of the reach of children.