Numb520
FDA Label NDC 63742-006

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 63742-006). 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 5%

Purpose

Local Anesthetic

Uses:

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Warnings

(For external use only)

Do Not Use This Product If

  • Pregnant or breastfeeding, ask a health professional before use
  • Tamper-evident shrink band around the container is broken.

When Using This Product

  • Do not exceed the recommended daily 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.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

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

  • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
  • Apply up to 6 times a day.
  • Children under 12 year 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, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

Package Labeling:

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