Hydroquinone powder, USP (10 grams) is a skin lightening agent whose mechanism of action involves reducing the amount of melanin present in the skin.
PRECAUTIONS (See Warnings):
Keep away from heat. Keep away from sources of ignition. Do not ingest. Do not breathe dust. Wear suitable protective clothing In case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes Keep away from incompatibles such as oxidizing agents, alkalis.
Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention.
After hydroquinone powder contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.
Monobenzone is the monobenzyl ether of hydroquinone. Monobenzone occurs as an off white, almost tasteless crystalline powder, soluble in alcohol and practically insoluble in water. Chemically, monobenzone is designated as p-(benzyloxy) phenol.
Monobenzone powder, USP is a depigmenting agent whose mechanism of action is not fully understood. The topical application of monobenzone in animals increases the excretion of melanin from the melanocytes. The same action is thought to be responsible for the depigmenting effect of the drug in humans. Monobenzone may cause destruction of melanocytes and permanent depigmentation. This effect is erratic and may take one to four months to occur while existing melanin is lost with normal sloughing of the stratum corneum. Hyperpigmented skin appears to fade more rapidly. Keep this, and all medications out of the reach of children. In case of accidental ingestion, call a physician or a Poison Control Center immediately.
PRECAUTIONS (See Warnings):
General. Monobenzone is for External Use Only. Following treatment with Monobenzone, the skin will be sensitive for the rest of the patient’s life. He/she must use sunscreens during exposure to the sun.
Information for the Patient. Monobenzone is a
potent depigmenting agent and is not a cosmetic skin bleach. Use of Monobenzone is contraindicated in any conditions other than disseminated vitiligo. Use only for final depigmentation in extensive vitiligo. Areas of normal skin distant to the site of application may become depigmented, and irregular, excessive, unsightly, and frequently permanent depigmentation may occur.
No long term studies have been performed to evaluate carcinogenic potential.
Pregnancy: Category C. Animal reproduction studies have not been conducted with Monobenzone. It is also not known whether Monobenzone can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Monobenzone should be given to a pregnant woman only if clearly needed.
Nursing Mothers. 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 Monobenzone is administered to a nursing woman.
Pediatric Use. The safety and effectiveness of Monobenzone in pediatric patients below the age of 12 years have not been established.
Mild, transient skin irritation and sensitization, including erythematous and eczematous reactions have occurred
Monobenzone is a potent depigmenting agent and is not a cosmetic skin bleach. Use of Monobenzone is contraindicated in any conditions other than disseminated vitiligo. Monobenzone frequently produces irreversible depigmentation, and it must not be used as a substitute for hydroquinone. Monobenzone is also contraindicated in individuals with a history of sensitivity or allergic reactions to this product, or any of its ingredients.
Monobenzone is a potent depigmenting agent, not a mild cosmetic bleach. Do not use except for final depigmentation in extensive vitiligo.