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AZELAIC ACID gel


  1. Inform Patients Using Azelaic Acid Gel Of The Following Information And Instructions:
  2. Inform Patients Using Azelaic Acid Gel, 15% Of The Following Information And Instructions:
  3. Azelaic Acid Gel, 15% Comes In A Tube:
  4. Azelaic Acid Gel Comes In A Tube:
  5. Manufactured By:
  6. Manufactured For:

Inform Patients Using Azelaic Acid Gel Of The Following Information And Instructions: 

  • For external use only.
  • Before applying azelaic acid gel, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel.
  • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
  • Avoid contact with the eyes, mouth and other mucous membranes. If azelaic acid gel does come in contact with the eyes, wash the eyes with large amounts of water and consult their healthcare providers if eye irritation persists.
  • Wash hands immediately following application of azelaic acid gel.
  • Cosmetics may be applied after the application of azelaic acid gel has dried.
  • Avoid the use of occlusive dressings or wrappings.
  • Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician.
  • If allergic reactions occur, discontinue use and consult their healthcare providers.
  • Advise patients to report any worsening of asthma to their healthcare providers.
  • Report abnormal changes in skin color to their healthcare providers.
  • To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages.

Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Iss. 6/2018

Inform Patients Using Azelaic Acid Gel, 15% Of The Following Information And Instructions: 

  • For external use only.

  • Before applying Azelaic Acid Gel, 15%, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel.

  • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

  • Avoid contact with the eyes, mouth and other mucous membranes. If Azelaic Acid Gel, 15% does come in contact with the eyes, wash the eyes with large amounts of water and consult their healthcare providers if eye irritation persists.

  • Wash hands immediately following application of Azelaic Acid Gel, 15%.

  • Cosmetics may be applied after the application of Azelaic Acid Gel, 15% has dried.

  • Avoid the use of occlusive dressings or wrappings.

  • Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of Azelaic Acid Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions occur, discontinue use and consult your physician.

  • If allergic reactions occur, discontinue use and consult their healthcare providers.

  • Advise patients to report any worsening of asthma to their healthcare providers.

  • Report abnormal changes in skin color to their healthcare providers.

  • To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages.

Azelaic Acid Gel, 15% Comes In A Tube: 

  • Tube instructions: Remove the cap before use. Squeeze the tube to dispense a small amount of Azelaic Acid Gel, 15%.

Manufactured by:
Tolmar, Inc.
Fort Collins, CO 80526

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807


04006126 Rev. 0 04/19

Azelaic Acid Gel Comes In A Tube: 

Tube instructions: Remove the cap before use. Squeeze the tube to dispense a small amount of azelaic acid gel.

Manufactured By: 

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured For: 

glenmark-logo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa

November 2018



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