Zensa Numbing Gel
Zensa Numbing Gel is an FDA drug label for the active ingredient LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% manufactured by Alera Skin Care Products Inc. administered by RECTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230927.
- Generic name
- LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%
- Manufacturer
- Alera Skin Care Products Inc.
- Product type
- HUMAN OTC DRUG
- Route
- RECTAL
- Dosage form
- N/A
- NDC
- 69805-400
- Application
- M015
- Label effective
- 20230927
About this product
Zensa Numbing Gel is an FDA-registered drug product whose active ingredient is LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%. It is labelled by Alera Skin Care Products Inc. taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 69805-400, application M015, label effective 20230927. 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.
What it is used for
Across FDA labelling, products containing LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% are most often described in connection with: temporary relief, local discomfort, anorectal disorders, pain soreness, burning temporarily, shrinks hemorrhoidal. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
USES For temporary relief of local discomfort associated with anorectal disorders. For temporary relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.
Dosage & Administration
DIRECTIONS Children under 12 years of age: Consult a doctor. Apply externally to the affected area up to 4 times daily.
Warnings
WARNINGS For external use only. Before use ask a doctor: •if you are presently taking a prescription drug for high blood pressure or depression. When using this product: •certain persons can develop allergic reactions to ingredients in this product. •if the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Frequently asked questions
What is Zensa Numbing Gel used for?
USES For temporary relief of local discomfort associated with anorectal disorders. For temporary relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.
Who makes Zensa Numbing Gel?
Alera Skin Care Products Inc. is the labeler of record for Zensa Numbing Gel.
What form does Zensa Numbing Gel come in?
administered by rectal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Zensa Numbing Gel prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Zensa Numbing Gel 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.