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Rhofade

Generic Name: oxymetazoline hydrochloride
Dosage Form: Topical Cream
Date of Approval: January 18, 2017
Company: Allergan plc

Treatment for: Rosacea

FDA Approves Rhofade

The U.S. Food and Drug Administration (FDA) has approved Rhofade (oxymetazoline hydrochloride) cream, the first and only alpha1A adrenoceptor agonist for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important Information

Rhofade cream is for skin (topical) use on the face only. Do not use this cream in your eyes, mouth, or vagina.

Keep Rhofade cream out of the reach of children.

Get medical help right away if you, a child, or anyone else swallows this cream.

What is Rhofade cream?

Rhofade 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 this cream is safe and effective in children under 18 years of age.

Before you start treatment, 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 thromboangiitis 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 the active ingredient in the cream will harm your unborn baby.
  • are breastfeeding. It is not known if the active ingredient in the cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

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

How should I use Rhofade cream?

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

Rhofade side effects

The most common side effects of Rhofade 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 Rhofade cream.

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

See also: Side effects (in more detail)

How should I store Rhofade cream?

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

General information about the safe and effective use of Rhofade cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this cream for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.

What are the ingredients?

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

Instructions For Use

Important:

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

Read and follow the steps below so that you use your tube of Rhofade cream correctly:

Step 1: Open the tube of Rhofade 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 Rhofade cream to your face, squeeze a pea-sized amount of cream from the tube onto your fingertip.

Step 3: Apply the pea-sized amount of cream to cover your entire face (forehead, nose, each cheek, and chin) one 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 the tube, place the cap back on the tube and press down and twist clockwise until it stops. The tube is child-resistant again.

Step 5: Wash your hands right away after applying the cream.

Read and follow the steps below so that you use your Rhofade cream pump correctly:

Step 1: Open the Rhofade cream pump by pushing down on the child-resistant cap and twisting it counterclockwise until the cap is removed. The clear sticker will break when opening for the first time. Note: When the cap is removed, the pump is not child-resistant.

Prime your cream pump before the first use only. Hold the pump upright and press down several times until the cream is dispensed onto a tissue. Pump 3 more times onto the tissue and throw away (discard) the tissue.

Your pump is now ready to use.

Step 2: To apply Rhofade cream to your face, press down on the pump one time to dispense a pea-sized amount of cream onto your fingertip.

Step 3: Apply the pea-sized amount of cream to cover your entire face (forehead, nose, each cheek, and chin) one 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 the pump, place the cap back on the pump and push down and turn clockwise until it stops. The pump is child-resistant again.

Step 5: Wash your hands right away after applying the cream.

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