Beaueli
FDA Label NDC 83462-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eubizrival Llc for the product Beaueli (NDC 83462-001). 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, directions, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 5%

Purpose

Local Anesthetic

Uses

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.

Warnings

For external use only

When using this product

  • Do not get into eyes.
  • Do not exceed recommend dosage unless directed by doctor.
  • Do not put this product into rectum by using fingers or any mechanical device or applicator.

    • Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days.
    • allergic reaction occurs to ingredients in this product.
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
    • symptoms clear up and return within a few days.

      • Keep out of reach of children.If swallowed, get medical help. Do not use if allergic to any ingredients.

      If pregnant or breastfeedingask a health professional before use.

Directions

  • When practical clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or bloating with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor
  • To use finger cots: roll one finger cot over finger. Gently squeeze cream on to finger cot. Smooth a layer of the cream.

Other Information

Store at room temperature. Avoid direct sunlight. Do not use if temper evident packaging has been breached or is missing.

Product Label

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