Hydroquinone

What is Hydroquinone?

• Hydroquinone is a skin bleaching cream used for the gradual bleaching of hyperpigmented skin conditions.

Hydroquinone 200

Hydroquinone ball and spoke

Hydroquinone-3d

What are the uses of this medicine?

• Hydroquinone skin bleaching cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

How does this medicine work?

• Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes.
• Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Is this medicine FDA approved?

• In 2006, the United States Food and Drug Administration revoked its previous approval of hydroquinone and proposed a ban on all over-the-counter preparations.
• The FDA officially banned hydroquinone in 2020 as part of a larger reform of the over-the-counter drug review process.
• The FDA stated that hydroquinone cannot be ruled out as a potential carcinogen.

How should this medicine be used?

Recommended dosage:

• Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician.
• If no improvement is seen after 2 months of treatment, use of this product should be discontinued.

Administration:

• Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Hydroquinone USP, 4% Skin Bleaching Cream

This medicine is available in fallowing brand namesː

• DERMESSE BALANCER
• HYDROQUINONE TIME RELEASE
• MEDISILKE

What side effects can this medication cause?

The most common side effects of this medicine include:

• dryness and fissuring of paranasal and infraorbital areas
• erythema
• stinging
• localized contact dermatitis

What special precautions should I follow?

• Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response further treatment is not advised.
• Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed.
• Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing.
• Avoid contact with eyes and mucous membranes.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• transient skin reddening and a mild burning sensation

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• HYDROQUINONE

Inactive Ingredients:

• WATER
• CETOSTEARYL ALCOHOL
• Glycerin
• LAURYL SULFATE
• Glycolic Acid
• ALPHA.-TOCOPHEROL
• Ascorbic Acid
• BISULFITE ION
• EDETIC ACID
• Methylparaben
• Propylparaben
• Butylated Hydroxytoluene

Who manufactures and distributes this medicine?

Manufactured for:

• Syntenza Pharmaceuticals LLC
• Edina, MN , USA

What should I know about storage and disposal of this medication?

• Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (15-30°C) (59-86°F).
• Darkening of this product is normal.

• Dailymed label info on Hydroquinone
• FDA Hydroquinone

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