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  5. Label Information: Zensa

FDA Label for Zensa

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zensa Product Label

The following document was submitted to the FDA by the labeler of this product Alera Skin Care Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.