Aclaro

Name: Aclaro

What is the most important information I should know about Aclaro (hydroquinone topical)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before using Aclaro (hydroquinone topical)?

You should not use this medicine if you are allergic to hydroquinone or peroxide.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

  • liver or kidney disease;

  • asthma or sulfite allergy; or

  • if you are using any antibiotic medicine.

It is not known whether hydroquinone topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether hydroquinone topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not give this medicine to anyone under 12 years old without medical advice.

How should I use Aclaro (hydroquinone topical)?

Hydroquinone topical is usually applied each morning and at bedtime. Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Hydroquinone topical is for use only on the skin. Avoid getting this medicine on your lips or inside your nose or mouth. Hydroquinone may cause numbness of these areas.

Before you start using hydroquinone topical, you may choose to apply a "test dose" to see if you have an allergic reaction to this medicine. Apply a very small amount of the medicine to a small area of healthy skin, and check the area within 24 hours. If there is no reaction other than minor redness, begin using the full prescribed amount of the medicine.

Do not use hydroquinone topical on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Wash your hands before and after applying this medicine, unless you are using it to treat the skin on your hands.

Apply this medicine only to the affected skin areas that need to be lightened. Try not to get any medicine on the skin around these areas.

Call your doctor if your symptoms do not improve after 2 months of treatment with hydroquinone topical.

Use hydroquinone topical regularly to get the most benefit.

Store at room temperature away from moisture and heat. Keep the container tightly closed when not in use.

What should I avoid while using Aclaro (hydroquinone topical)?

Avoid exposure to sunlight or tanning beds. Hydroquinone topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Some hydroquinone products may contain sunscreen. Check the medicine label or ask your doctor to be sure.

Avoid getting this medicine in your eyes.

Hydroquinone topical may make your skin more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing lotion as needed.

Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may stain your skin. This staining can usually be removed with soap and water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

What are some other side effects of Aclaro?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry skin.
  • Skin irritation.
  • Redness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Aclaro, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aclaro. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Aclaro.

Review Date: October 4, 2017

Manufacturer

  • Innocutis

  • Innocutis Holdings, LLC

  • JSJ Pharmaceuticals

For Healthcare Professionals

Applies to hydroquinone topical: compounding powder, topical cream, topical emulsion, topical gel, topical solution

Dermatologic

Dermatologic side effects have included localized contact dermatitis. Exogenous ochronosis (involving over 10,000 exposures under careful clinical supervision) has been reported at an incidence of 22 cases in more than 50 years.[Ref]

Some side effects of Aclaro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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