WAXUP Numbing

LIDOCAINE HYDROCHLORIDE TOPICAL HUMAN OTC DRUG

WAXUP Numbing is an FDA drug label for the active ingredient LIDOCAINE HYDROCHLORIDE manufactured by CONSTRUSOLUTION, LLC administered by TOPICAL. 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 20231106.

Generic name
LIDOCAINE HYDROCHLORIDE
Manufacturer
CONSTRUSOLUTION, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
83163-386
Application
M015
Label effective
20231106

About this product

WAXUP Numbing is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE. It is labelled by CONSTRUSOLUTION, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83163-386, application M015, label effective 20231106. It is one of 110 FDA drug label records sharing the active ingredient LIDOCAINE 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.

What it is used for

Across FDA labelling, products containing LIDOCAINE HYDROCHLORIDE are most often described in connection with: helps relieve, local itching, perianal area, temporary relief, pain irritation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Lidocaine HCL 5.00% Purpose Anorectal (hemorrhoidal)

Indications & Usage

Uses: Helps relieve the local itching and discomfort in the perianal area For the temporary relief of pain, irritation or burning.

Dosage & Administration

Directions: Adults:• When practical, cleanse the affected area "with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Warnings

Warnings: For external use only. Do not: exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using fingers or any mechanical device or applicator. When using this product: If condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if: If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product. Allergy alert: Keep out of raech of children. If swallowed, get medical help, or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

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How products containing LIDOCAINE HYDROCHLORIDE compare

FDA lists 110 drug label records with LIDOCAINE 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.

Dosage formProductsManufacturerProducts
— — Medical Purchasing Solutions, LLC 18
— — Asclemed USA, Inc. 6
— — Water-Jel Technologies 6
— — SKINS SEXUAL HEALTH LIMITED 5
— — Nantong Health & Beyond Hygienic Products Inc. 4

Frequently asked questions

What is WAXUP Numbing used for?
Uses: Helps relieve the local itching and discomfort in the perianal area For the temporary relief of pain, irritation or burning.

Who makes WAXUP Numbing?
CONSTRUSOLUTION, LLC is the labeler of record for WAXUP Numbing. 110 FDA label records share the active ingredient LIDOCAINE 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 WAXUP Numbing 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 WAXUP Numbing 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 HYDROCHLORIDE?
Yes. 110 FDA drug label records list LIDOCAINE 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 WAXUP Numbing 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.