Zensa Cream
FDA Label NDC 69805-786

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alera Skin Care Products Inc. for the product Zensa (NDC 69805-786). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, 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

Topical Anaesthetic

Uses

  • For the temporary relief of local discomfort associated with anorectal disorders
  • For the temporary relief of pain, soreness, and burning

Warnings

​For external use only.

When Using This Product

  • avoid contact with eyes
  • do not exceed the recommended daily dosage unless directed by a physician
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • certain persons can develop allergic reactions to ingredients in this product.  If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor

Stop Use And Ask A Doctor If

  • condition worsens or does not improve within 7 days
  • bleeding occurs

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Adults: when practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly.  Gently dry by patting or blottig with toilet tissue or a soft cloth before application of this product.  Children under 12 years of age: consult a physician.
  • Apply externally to the affected area up to 6 times daily

Other Information

See enclosed consumer leaflet.

Store at 15°C to 30°C.  Protect from freezing

Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Vitamin E Acetate, Purified Water

Package Label.Principal Display Panel

​NDC 69805-786-01​

​ZENSA

TOPICAL ANESTHETIC CREAM - ANORECTAL

WITH 5% LIDOCAINE

30 g

Zensa (Zensa)

Zensa (Zensa)

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