Numb520
FDA Label NDC 63742-012

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 63742-012). 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 ingredients, purpose, uses:, warnings, do not use this product if, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine HCL 5%

Phenylephrine HCL, 0.25%

Purpose

Local Anesthetic

Vasoconstrictor

Uses:

For the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.

Warnings

  • for external use only.
  • avoid contact with the eyes.

Do Not Use This Product If

  • pregnant or breastfeeding, ask a health professional before use.
  • Tamper Evident "Do not use this product" if safety seal is broken or missing.
  • you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.

When Using This Product

  • do not exceed the recommended daily usage.
  • 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.
  • if swallowed, call your Poison Control Center at 1(800) 222-1222.
  • if condition worsens or does not improve within 7 days, consult a doctor.

Stop Use And Ask A Doctor If

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

Directions

  • clean the affected area.
  • sensitivity and possible allergy tests advised prior to use. Spray spraingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.
  • apply to the affected area up to 4 times daily.
  • 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, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite

Package Labeling:

Label (Label)

Label (Label)

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