SECONDARY NUMB Lidocaine Phenylephrine Gel

SECONDARY NUMB Lidocaine Phenylephrine Gel is an FDA-registered drug product whose active ingredient is LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by LALANI Rx Consulting, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83120-378, application M015, label effective 20231106. It is one of 4 FDA drug label records sharing the active ingredient LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE. 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 LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporary relief, pain temporarily, shrinks hemorrhoidal, anorectal discomfort. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids

Directions Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed

Warnings For external use only Do not use if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination Ask a doctor before use if you are • presently taking medicine for high blood pressure or depression When using this product • do not put it into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic reaction to product occurs. Keep out of reach of children. If swallowed, call poison control centre or get medical help right away

FDA lists 4 drug label records with LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is SECONDARY NUMB Lidocaine Phenylephrine Gel used for?
Uses • Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids

Who makes SECONDARY NUMB Lidocaine Phenylephrine Gel?
LALANI Rx Consulting, Inc. is the labeler of record for SECONDARY NUMB Lidocaine Phenylephrine Gel. 4 FDA label records share the active ingredient LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does SECONDARY NUMB Lidocaine Phenylephrine Gel come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is SECONDARY NUMB Lidocaine Phenylephrine 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.

Are there other products containing LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE?
Yes. 4 FDA drug label records list LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has SECONDARY NUMB Lidocaine Phenylephrine 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.