Numb520
FDA Label NDC 63742-030

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 Numb520 (NDC 63742-030). 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 this product if, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine HCl 5%

Purpose

Local Anesthetic

Uses:

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

Warnings

(For external use only)

Do Not Use This Product If

  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • tamper evident "Do not use this product" if seal is broken or missing.

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 finger 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 rinse 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

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

Package Labeling:

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