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Compounded, not FDA approved

Hydroquinone 12%

Compounded hydroquinone 12% topical cream for hyperpigmentation

A compounded hydroquinone 12% topical cream prescribed after a provider evaluation as part of a skin care plan for hyperpigmentation such as melasma and dark spots. It is not FDA approved.

Compounded drugs are not FDA approved. FDA does not review compounded drugs for safety, effectiveness, or quality before marketing.

Prescription medication. Medication availability, formulation, packaging and pharmacy fulfillment vary based on the patient's prescription and location.
Hydroquinone 12%
At a glance
Dosing and schedule are set by your provider
Form and route
Topical cream
Frequency
As directed by your prescriber
Storage
As directed on your pharmacy label
Category
Gallery

See it before your first visit

Photographs of the medication as dispensed.

Overview

What it is

Hydroquinone 12% is a compounded topical cream prescribed by a licensed provider as part of a skin care plan for hyperpigmentation, such as melasma, sun spots, and dark marks left after acne or irritation. Hydroquinone is a skin-lightening ingredient.

It is a compounded medication. It is not FDA approved, and the FDA has not evaluated it for safety, effectiveness, or quality. It is a high strength, and it is not appropriate for everyone. Your provider decides whether it is right for you.

Mechanism

How it works

Hydroquinone reduces the activity of tyrosinase, an enzyme skin cells use to make melanin, the pigment that gives skin its color. Applied to a small area of darkened skin, it can lighten that area over time. Daily sunscreen is a key part of any plan, because sun exposure can bring pigment back. Human evidence for this specific compounded strength is limited, and results vary.

The program

What to expect

Your pharmacy label and provider will give you directions. A typical routine is to wash and dry the skin, apply a thin layer only to the dark areas as directed, and use broad-spectrum sunscreen every day. Your provider may ask you to test a small area first and may limit how long you use it.

Redness, dryness, and mild irritation can happen, especially early on. Your provider will schedule follow-ups to check your skin and decide whether to continue, change, or stop treatment. Results vary and no outcome is guaranteed.

Candidacy

Who it is for

This cream is prescribed after an evaluation by a licensed provider. It may not be appropriate for everyone. Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding, if you have sensitive skin or eczema, or if you have had a reaction to hydroquinone or other skin lighteners. Share every skin care product and medication you use, including other lightening agents, peels, and retinoids.

Tolerability

Side effects

Common side effects include redness, dryness, itching, stinging, and skin irritation. Contact dermatitis can occur. Some people develop temporary lightening of the skin around the treated area.

Long-term or excessive use of hydroquinone has been linked to ochronosis, a rare condition that causes blue-black skin discoloration. Stop use and call your provider if you notice darkening, bluish-gray spots, severe irritation, swelling, blistering, or signs of an allergic reaction.

Safety information and disclosures

Read this before you start

Compounded, not FDA approved
Prescription only
Provider supervision required

Compounded drugs are not FDA approved. FDA does not review compounded drugs for safety, effectiveness, or quality before marketing.

Medication availability, formulation, packaging and pharmacy fulfillment vary based on the patient's prescription and location.

Compounded medication. This medication is compounded by a pharmacy for an individual patient. It is not FDA approved, and the FDA has not evaluated it for safety, effectiveness, or quality.

Limited evidence. Human evidence for this compounded strength is limited. Your provider will talk with you about what is and is not known.

Ochronosis and prolonged use. Prolonged or excessive use of hydroquinone can cause paradoxical darkening of the skin (ochronosis). Use only as directed and for the length of time your provider recommends.

Sun protection. Hydroquinone can leave skin more sensitive to sun. Use broad-spectrum sunscreen daily, wear protective clothing, and avoid tanning beds and sunlamps.

Do not apply to broken, sunburned, or irritated skin, and keep it away from eyes, mouth, and mucous membranes. For external use only. Apply only to the areas your provider directs.

Pregnancy and breastfeeding. Talk to your provider before using. Systemic absorption of hydroquinone can occur.

Allergy. Do not use if you are allergic to hydroquinone or any ingredient in the cream. Check your pharmacy label for the full ingredient list.

This page is for general information and is not medical advice.

If you are having a medical emergency, call 911. The information on this page is general and educational. It does not establish a provider relationship, does not replace a consultation, and should not be used to diagnose or treat any condition.
Questions

Common questions

Is hydroquinone 12% FDA approved?

No. It is a compounded medication. The FDA has not evaluated it for safety, effectiveness, or quality.

What is hydroquinone 12% used for?

Licensed providers prescribe it as part of a skin care plan for hyperpigmentation, such as melasma, sun spots, and dark marks after acne or irritation. Your provider decides if it is appropriate for you.

Do I need a prescription for hydroquinone 12%?

Yes. It is a compounded prescription medication, prepared by a pharmacy after a provider evaluates you.

How do I apply it?

Follow your pharmacy label and provider directions. Typically you apply a thin layer only to the dark areas on clean, dry skin and use sunscreen every day.

What are the risks of long-term use?

Prolonged or excessive use can cause ochronosis, a rare skin darkening. Your provider will tell you how long to use it and will monitor your skin.

Can I use it if I am pregnant or breastfeeding?

Talk to your provider before using it.

Can I use hydroquinone with other skin care products?

Ask your provider. Retinoids, peels, and exfoliants can increase irritation.