Topical Anesthetic Anorectal Cream
FDA Label NDC 68848-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermtech Labs Inc. Dba Gd Labs for the product Topical Anesthetic Anorectal Cream (NDC 68848-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient     Purpose
Lidocaine 5%  ..... Topical Anesthetic

Otc - Purpose

Temporarily relieves local pain and discomfort of anorectal area.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Chilren

Indications & Usage

Stop use and ask your doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days.

Warnings

  • For Rectal use only
  • For external use on intact skin only
  • Do not use if pregnant or breast-feeding
  • Do not exceed the recommended daily dosage unless directded by a doctor
  • Avoid contact with eyes and mucous membranes
  • You may experience temporary redness or stinging where the product is applied
  • If irritation persists, consult your doctor
  • Do not put product into the rectum by using fingers or any mechanical device or applicator

Dosage & Administration

  • Children 12 and under, consult a physician prior to use
  • When practical, clean area with mild soap and water. Rinse thoroughly and gently dry by blotting with tissue or soft cloth before applying.
  • Apply to the affected area up to 6 times daily

Inactive Ingredient

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate-80, PPG-12/SMDI Copolyme, Propylene Glycol, Trolamine, Water

Package Label.Principal Display Panel

Numb & Number

Topical Anesthetic

Anorectal Cream

Net Wt 20 oz / 600g

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