Numquick Topical Analgesic Gel
FDA Label NDC 67194-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose, Ltd. for the product Numquick Topical Analgesic (NDC 67194-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses:, warnings:, do not use:, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

(-) Epinephrine HCL w/w 0.01%

Lidocaine HCl 5% w/w

Purpose

Vasoconstrictor

Local Anesthetic

Uses:

Temporarily relieves local discomfort or pain or burning associated with anorectal disorders.

Warnings:

​External use only

Allergy alert: ​certain persons can develop allergic reactions to the ingredients in this product.

Do Not Use:

this product in the rectum by using fingers or any mechnical device or applicator.

When Using This Product

do not use more than directed.

Stop Use And Ask A Doctor

if pain worsens or does notimprove in 7 days

  • if redness, irritation, swelling, pain or other symptoms develop or increase
  • if bleeding occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • adults: clean the affected area with mild soap and warm water and rinse thoroughly
  • dry gently
  • apply 1-2 g. externally to the affected area up to 4 times daily
  • children under 12 years: ask a doctor.

Other Information:

Store in a cool dark place

Inactive Ingredients:

Aqua (DI water), chlorobutanol, methylcellulose, sodium EDTA, sodium metabisulfite

Questions?

Call Toll Free 888-452-4946

Package Labeling:

Outer (Outer)

Outer (Outer)

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