Rhofade 1 g/100g

OXYMETAZOLINE HYDROCHLORIDE · CREAM · EPI Health, LLC

No Recall History

Plain English

Rhofade is a cream containing oxymetazoline hydrochloride at 1 g/100g, taken topical. Manufactured by EPI Health, LLC.

Key Facts

Brand Name: Rhofade
Generic Name: OXYMETAZOLINE HYDROCHLORIDE
NDC Code (Product): 71403-003
Manufacturer: EPI Health, LLC
Strength: 1 g/100g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: NDA208552
Marketing Start: 01/18/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

application site erythema84 reports

drug ineffective62 reports

rosacea54 reports

fatigue50 reports

nausea50 reports

application site pain49 reports

pain47 reports

erythema45 reports

pruritus43 reports

condition aggravated39 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE RHOFADE ® (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Rhofade cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For topical use only. RHOFADE cream is not for oral, ophthalmic, or intravaginal use. Prime the RHOFADE cream pump before using for the first time. To do so, with the pump in the upright position, repeatedly depress the actuator until cream is dispensed and then pump three times. Discard the cream from priming actuations. It is only necessary to prime the pump before the first dose. RHOFADE cream tubes do not require priming. Apply a pea-sized amount of RHOFADE 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 RHOFADE cream. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Prime pump bottle before initial use and discard product from first three pumps. ( 2 ) Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. ( 2 ) Wash hands after application. ( 2 )

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 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. 7.2 Monoamine Oxidase Inhibitors Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

Adverse Reactions

6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EPI Health, LLC at 1-800-499-4468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 489 subjects with persistent facial erythema associated with rosacea were treated with RHOFADE cream once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with RHOFADE cream once daily for up to one year in a long-term (open-label) clinical trial. Adverse reactions that occurred in at least 1% of subjects treated with RHOFADE cream through 4 weeks of treatment are presented in Table 1 below. Table 1: Adverse Reactions Reported by…

Frequently Asked Questions

What is Rhofade used for?

Rhofade contains OXYMETAZOLINE HYDROCHLORIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is Rhofade a controlled substance?

Rhofade is not classified as a controlled substance by the DEA.

What is the generic name for Rhofade?

The generic name for Rhofade is OXYMETAZOLINE HYDROCHLORIDE. There are 12 other brand versions of OXYMETAZOLINE HYDROCHLORIDE.

What is the NDC code for Rhofade 1 g/100g?

The NDC (National Drug Code) for Rhofade 1 g/100g is 71403-003, listed by EPI Health, LLC.

Product NDC

71403-003

Package NDC

71403-003-15

Other Oxymetazoline Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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