SkinActive ingredient
Oxymetazoline
Alpha-adrenergic agonist1 FDA label read
Oxymetazoline cream, sold as Rhofade, addresses the one part of rosacea the other medications here do not: the persistent facial redness. Soolantra and Epsolay are approved for the inflammatory bumps of rosacea; this label is about erythema, and the two problems are treated by different documents.
Highlights of the labels
- Rhofade
- Persistent facial redness of rosaceacovers skin
- Supply
- Prescription only
- Generic
- 1 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| RhofadeMayne Pharma | What its label approvesPersistent facial redness of rosaceaCovers skin | SupplyPrescription | Label version13 July 2026 |
How it works
The label describes oxymetazoline as an alpha-1A adrenoceptor agonist that acts as a vasoconstrictor: it narrows blood vessels. Applied to the face, that is the mechanism aimed at persistent redness. It is for topical use only.
Mechanism of action, Rhofade label
Oxymetazoline is an alpha 1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.
What the FDA approved it for
The approved uses, as worded in the label.
Oxymetazoline Hydrochloride Cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Forms and strengths
The presentations and strengths listed in the label.
- Oxymetazoline Hydrochloride Cream, 1% is a white to off-white cream.
- Each gram of cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- For topical use only.
- Oxymetazoline Hydrochloride Cream is not for oral, ophthalmic, or intravaginal use.
- Apply a pea-sized amount of Oxymetazoline Hydrochloride Cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips.
- Wash hands immediately after applying Oxymetazoline Hydrochloride Cream.
- Not for oral, ophthalmic, or intravaginal use.
- Prime pump bottle before initial use and discard product from first three pumps.
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain.
Warnings and precautions
The warnings and precautions section of the label.
- Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
- Use with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
- Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
Contraindications
Situations in which the label states the medication must not be used.
None. The label states that there are no contraindications.
Drug interactions
Interactions the label singles out.
- Anti-hypertensives/Cardiac Glycosides Alpha-adrenergic agonists, as a class, may impact blood pressure.
- Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised.
- Caution should also be exercised in patients receiving alpha 1 adrenergic receptor antagonists such as in the treatment of cardiovascular disease, benign prostatic hypertrophy, or Raynaud's disease. Monoamine Oxidase Inhibitors Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
There are no available data on Oxymetazoline Hydrochloride Cream use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. A literature article describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline (with no decongestant exposure in the first trimester) and renal collecting system anomalies.
Generic or brand
The register lists one approved generic application for oxymetazoline hydrochloride in this form, alongside the brand approval.
The FDA label database lists 1 approved generic applications for this ingredient.
What affects the cost
The acquisition cost below covers the prescription cream. Oxymetazoline is also a familiar ingredient of over-the-counter nasal sprays; those are different products at different concentrations and have nothing to do with this page or its pricing. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per gram | Brand$23.47 (range $23.46 to $23.48, 34 listings) |
Median of 34 listings. Effective dates 2025-12-17 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Is Rhofade the same as the nose spray oxymetazoline?
- The active ingredient is related, the products are not interchangeable: Rhofade is a facial cream with its own approved label for rosacea redness, explicitly not for oral, ophthalmic or intravaginal use. Nasal sprays are separate over-the-counter products.
- Does Rhofade treat the bumps of rosacea?
- Its label covers persistent facial erythema - the redness. The inflammatory lesions are the territory of other labels, such as Soolantra and Epsolay, each with its own page here. The comparison page reads Rhofade and Soolantra side by side.
- Who does the label tell to be cautious?
- It advises caution for people with cardiovascular disease and related conditions - the label notes alpha-adrenergic agonists as a class may impact blood pressure - and for those with cerebral or coronary insufficiency, Raynaud's phenomenon and several other conditions, quoted in full on this page.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Rhofade
Mayne Pharma. Label version 3, effective 13 July 2026.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.