Numb 100
FDA Label NDC 63742-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinical Resolution Laboratory, Inc. for the product Numb 100 (NDC 63742-003). 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 active ingredient, purpose, uses:, warnings, do not use, pregnant or breast-feeding,, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses:

For the temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warnings

(For external use only)

Do Not Use

this product if

Pregnant Or Breast-Feeding,

  • ask a health professional before use.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately.
  • Tamper Evident "Warranty Void...Seal..."label atop the container is broken.

When Using This Product

  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using fingers or any medical device or applicator.

Stop Use And Ask A Doctor If

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out Of Reach Of Children

In case of accidental ingestion, seek medical attention immediately.

Directions

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rise thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
  • Apply up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other Information

  • Keep away from direct sunlight or heat.
  • Store in room temperature (59-86°F / 15-30°C).

Inactive Ingredients

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol, Allantoin, Tocopheryl Acetate, Polysorbate-80

Package Labeling:

Label (Label)

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