Rhofade Cream for Rosacea

Rhofade cream is a topical prescription medicine used to treat facial redness due to rosacea that is persistent or does not go away in adults.

It is not known if Rhofade cream is safe to use in children under 18 years of age.

Active ingredient: oxymetazoline hydrochloride

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

Before you use RHOFADE cream, tell your doctor about all of your medical conditions, including if you:

• have or have had problems with blood circulation or a stroke

• have heart, blood pressure, or blood vessel problems. Call your doctor or get medical help if these conditions worsen.

• have Sjögren’s Syndrome

• have scleroderma

• have Raynaud’s phenomenon

• have thromboangiitis obliterans

• have narrow-angle glaucoma. Call your doctor for help if your glaucoma worsens.

• have open sores or irritated skin on the face

• are pregnant or planning to become pregnant. It is not known if Rhofade cream can harm your
• unborn baby.

• are breastfeeding. It is not known if Rhofade cream can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you use Rhofade cream.

• Tell your doctor about all the medicines you take, including skin products, vitamins, prescriptions, over-the-counter medicines, and herbal supplements. Using Rhofade cream with certain other medicines can cause serious side effects.

• Apply a pea-sized amount once daily to cover the entire face (chin, nose, each cheek, and forehead) avoiding the eyes and lips

• Use Rhofade cream exactly as your doctor tells you. Do not use more of the Rhofade cream.

• Do not use Rhofade cream in your eyes, mouth, lips, or vagina.

• Wash your hands after using Rhofade cream.

• Do not apply Rhofade cream to open wounds or irritated skin.

• dermatitis (skin reactions)

• itching

• worsening of rosacea pimples

• redness

• pain

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

Alpha-adrenergic agonists may impact blood pressure. Caution in using drugs such as anti-hypertensives,
beta-blockers, and/or cardiac glycosides are advised.

Caution should be taken in patients receiving alpha 1 adrenergic receptor antagonists such as in the treatment of benign prostatic hypertrophy, Raynaud’s disease, or cardiovascular disease.

Caution is advised in patients taking MAO inhibitors which can affect the uptake of circulating amines and metabolism.

Rhofade cream is not for oral use but if oral ingestion occurs. Monitor patient closely and administer appropriate supportive measures as necessary. Accidental ingestion of topical solutions (nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, hypotension, hypertension, sedation, vomiting, bradycardia, somnolence, mydriasis, stupor, lethargy, tachycardia, decreased respiration, hypothermia, drooling, and coma.