UPNEEQ

UPNEEQ is an FDA-registered drug product whose active ingredient is OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC. It is labelled by RVL Pharmaceuticals, Inc. taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 73687-062, application NDA212520, label effective 20260723. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC are most often described in connection with: upneeq indicated, treatment acquired, blepharoptosis adults. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Instill one drop of UPNEEQ into one or both ptotic eye(s) once daily. Discard the single patient-use container immediately after dosing. Contact lenses should be removed prior to instillation of UPNEEQ and may be reinserted 15 minutes following its administration. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 15 minutes between applications. Instill one drop into one or both ptotic eye(s) once daily. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS Most common adverse reactions (incidence 1-5%) are: punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RVL Pharmaceuticals, Inc. at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely 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 360 subjects with acquired blepharoptosis were treated with UPNEEQ once daily in each eye for at least 6 weeks in three controlled Phase 3 clinical trials, including 203 subjects treated with UPNEEQ for 6 weeks and 157 subjects treated with UPNEEQ for 12 weeks. Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

What is UPNEEQ used for?
1 INDICATIONS AND USAGE UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. ( 1 )

Who makes UPNEEQ?
RVL Pharmaceuticals, Inc. is the labeler of record for UPNEEQ.

What form does UPNEEQ come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is UPNEEQ prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has UPNEEQ been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.