Medication-info.com Search Menu

Zyclara (Imiquimod): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
37.5 mg/g, 2.5 mg/g
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Zyclara

What is ZYCLARA Cream?

  • ZYCLARA Cream, 2.5% and 3.75% are prescription medicines used on the skin (topical) to treat actinic keratosis on the face or balding scalp in adults with a normal immune system.
  • ZYCLARA Cream, 3.75% is a prescription medicine used on the skin (topical) to treat warts on the outside of the genitals (external) and around the outside of the anus (perianal) in people 12 years and older.

It is not known if ZYCLARA Cream is safe and effective in the treatment of:

  • human papilloma virus (HPV) disease of the urethra, the inside of the vagina (intravaginal), cervix, rectum, or inside of the anus (intra-anal)
  • actinic keratosis, when treated with more than one 2-cycle treatment course in the same affected area
  • people with extreme sensitivity to sunlight (xeroderma pigmentosum)
  • a type of skin cancer called superficial basal cell carcinoma
  • people who have a weakened immune system

It is not known if ZYCLARA Cream is safe and effective for the treatment of actinic keratosis in children less than 18 years of age.

It is not known if ZYCLARA Cream is safe and effective in children less than 12 years of age for external genital and perianal warts.

Before using ZYCLARA Cream, tell your healthcare provider about all of your medical conditions, including if you:

  • have problems with your immune system, including autoimmune disease or long-lasting (chronic) graft versus host disease
  • are being treated or have been treated with other medicines or surgery. You should not use ZYCLARA Cream until your skin has healed from other treatments.
  • have other skin problems or sunburn.

  • are pregnant or plan to become pregnant. It is not known if ZYCLARA Cream can harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if ZYCLARA Cream passes into your breast milk. If you breastfeed during treatment with ZYCLARA Cream, avoid contact of your treated skin with your baby’s mouth or eyes. Talk to your healthcare provider about the best way to feed your baby if you use ZYCLARA Cream.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ZYCLARA Cream?

  • Use ZYCLARA Cream exactly as your healthcare provider tells you to use it.
  • Your healthcare provider should show you how to apply ZYCLARA Cream.
  • Apply ZYCLARA Cream 1 time a day just before your bedtime. Do not use more ZYCLARA Cream than you need to cover the affected area. Using too much ZYCLARA Cream, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effects.
  • Your healthcare provider may prescribe ZYCLARA Cream in a packet or pump.
  • ZYCLARA Cream packet:
  • Open a packet of ZYCLARA Cream just before use.
  • After applying ZYCLARA Cream, the opened packet should be thrown away even if all the ZYCLARA Cream was not used.
  • ZYCLARA Cream pump:
  • Remove the cap.
  • Before using the pump for the first time only, prime the pump by pressing the top of the pump all the way down repeatedly until the cream appears. The cream obtained from priming should be dispensed into a tissue and then thrown away (discarded). The pump is now primed and is ready to use. You will not have to repeat this priming process during your treatment.
  • When dispensing the cream, slightly tilt the pump as shown.
  • Firmly press the top of the pump all the way down to dispense the cream onto your hand or fingertip.

Applying ZYCLARA Cream:

  • Wash the area where ZYCLARA Cream will be applied with mild soap and water.
  • Allow the area to dry.
  • Wash your hands well.
  • Apply a thin layer of ZYCLARA Cream only to the affected area(s) to be treated.
  • Rub ZYCLARA Cream in all the way until you cannot see the cream on the affected area(s).
  • Wash your hands well after applying ZYCLARA Cream.
  • After about 8 hours, wash the treated area(s) with mild soap and water. Do not leave ZYCLARA Cream on your skin longer than prescribed. If you forget to apply ZYCLARA Cream, apply the next dose of ZYCLARA Cream at your regularly scheduled time.

When using ZYCLARA Cream for actinic keratosis:

  • Do not get ZYCLARA Cream in or near your lips, mouth, or eyes, or inside your nose.
  • If you get ZYCLARA Cream in your mouth or in your eyes, rinse well with water right away.
  • Apply ZYCLARA Cream to the skin of the affected area for 2 weeks, then stop using for 2 weeks, then apply again for 2 weeks.
  • If you have been prescribed ZYCLARA Cream packets, do not use more than 2 packets for each daily application.
  • If you have been prescribed ZYCLARA Cream pump, do not dispense more than 2 pumps for each daily application.

When using ZYCLARA Cream for external genital or perianal warts:

  • Do not get ZYCLARA Cream in your anus or vagina.
  • Treatment should continue until the warts are completely gone or for up to 8 weeks. ZYCLARA Cream will not cure your genital or perianal warts. New warts may develop during treatment with ZYCLARA Cream.
  • Uncircumcised males treating warts under their penis foreskin must pull their foreskin back and clean before treatment and clean daily during treatment.
  • Females treating genital warts must be careful when applying ZYCLARA Cream around the vaginal opening.
  • If you have been prescribed ZYCLARA Cream packets, do not use more than 1 packet for each daily application.
  • If you have been prescribed ZYCLARA Cream pump, do not dispense more than 1 pump for each daily application.

What should I avoid while using ZYCLARA Cream?

  • Do not cover the treated area with bandages or other closed dressings. Cotton gauze dressings can be used, if needed. Cotton underwear can be worn after applying ZYCLARA Cream to the genital or perianal area.
  • Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with ZYCLARA Cream. Use sunscreen and wear protective clothing if you go outside during daylight.
  • Do not have sexual contact including genital, anal, or oral sex when ZYCLARA Cream is on your genital or perianal skin. ZYCLARA Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy.
  • Avoid using ZYCLARA Cream and any other imiquimod products in the same treatment area. They have the same active ingredients (imiquimod) and may increase your risk for side effects.

What are the possible side effects of ZYCLARA Cream?

ZYCLARA Cream may cause serious side effects, including:

  • Treatment site skin reactions. Skin reactions including drainage (weeping) or breakdown of the outer layer of your skin (erosion) can happen after a few applications of ZYCLARA Cream. Swelling outside of the vagina (vulvar swelling) may happen in females. Females should take special care if applying the cream at the opening of the vagina because skin reactions can cause pain or swelling, and may cause problems passing urine. If you get skin reactions, wash the treated area with mild soap and water.
  • Stop ZYCLARA Cream right away and call your healthcare provider if you get any skin reactions that affect your daily activities, or that do not go away.
  • Flu-like symptoms. Tell your healthcare provider if you get tiredness, nausea, vomiting, fever, chills, muscle pain, and joint pain.

Your healthcare provider may temporarily stop or completely stop your treatment with ZYCLARA Cream if you develop

treatment site skin reactions or flu-like symptoms.

The most common side effects of ZYCLARA Cream include:

  • skin reactions including skin redness, scabbing, crusting, flaking, scaling, dryness, swelling

    • headache
    • itching at the treatment area
    • tiredness
    • nausea
    • skin irritation
    • pain at the treatment area

These are not all of the possible side effects of ZYCLARA Cream.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZYCLARA Cream?

  • Store ZYCLARA Cream at room temperature between 68°F to 77°F (20°C to 25°C).

    • Store ZYCLARA Cream pumps upright.
    • Do not freeze.
    • Safely throw away ZYCLARA Cream that is out of date, unused or partially used.

Keep ZYCLARA Cream and all medicines out of the reach of children.

General information about the safe and effective use of ZYCLARA Cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZYCLARA Cream for a condition for which it was not prescribed. Do not give ZYCLARA Cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZYCLARA Cream that is written for health professionals.

What are the ingredients in ZYCLARA Cream?

Active Ingredient: imiquimod

Inactive Ingredients: benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum.

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

Patented. See https://patents.ortho-dermatologics.com for US patent information.

ZYCLARA is a trademark of Bausch Health Companies Inc. or its affiliates.

For more information, go to www.ZYCLARACream.com or call 1-800-321-4576

© 2024 Bausch Health Companies Inc. or its affiliates

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 09/2024

9740701

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022483 · View the label on DailyMed

Revision date stated in the text: September 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Zyclara

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Imiquimod
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) BAUSCH
FDA approval NDA 022483New Drug Application (NDA) Approved March 25, 2010
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Imiquimod with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
37.5 mg/g – 0.25 g in 1 packet / 4 in 1 carton NDC 99207-270-01
37.5 mg/g – 0.25 g in 1 packet / 28 in 1 carton NDC 99207-270-28
37.5 mg/g – 7.5 g in 1 bottle, pump / 1 in 1 carton NDC 99207-271-75
37.5 mg/g – 7.5 g in 1 bottle, pump / 1 in 1 carton NDC 99207-271-01
2.5 mg/g – 7.5 g in 1 bottle, pump / 1 in 1 carton NDC 99207-276-75
2.5 mg/g – 7.5 g in 1 bottle, pump / 1 in 1 carton NDC 99207-276-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.