FOR EXTERNAL USE ONLY
Monobenzone Cream 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 than does normal skin, and exposure to sunlight reduces the depigmenting effect of the drug. The histology of the skin after depigmentation with topical monobenzone is the same as that seen in vitiligo; the epidermis is normal except for the absence of identifiable melanocytes.
INDICATIONS AND USAGE:
Monobenzone Cream is indicated for final depigmentation in extensive Vitiligo. Monobenzone Cream is applied topically to permanently depigment normal skin surrounding vitiliginous lesions in patients with disseminated (greater than 50 percent of body surface area) idiopathic vitiligo. Monobenzone Cream is not recommended in freckling; hyperpigmentation caused by photosensitization following the use of certain perfumes (berlock dermatitis); melasma (chloasma) of pregnancy; or hyperpigmentation resulting from inflammation of the skin. Monobenzone Cream is not effective for the treatment of cafe-au-lait spots, pigmented nevi, malignant melanoma or pigmentation resulting from pigments other than melanin (e.g.: bile, silver, or artificial pigments).
Monobenzone Cream contains a potent depigmenting agent and is not a cosmetic skin bleach. Use of Monobenzone Cream is contraindicated in any conditions other than disseminated vitiligo. Monobenzone Cream frequently produces irreversible depigmentation, and it must not be used as a substitute for hydroquinone.
Monobenzone Cream is also contraindicated in individuals with a history of sensitivity or allergic reactions to this product, or any of its ingredients.
DOSAGE AND ADMINISTRATION:
A thin layer of Monobenzone Cream should be applied and rubbed into the pigmented area two or three
times daily, or as directed by physician. Prolonged exposure to sunlight should be avoided during treatment
with Monobenzone Cream, or a sunscreen should be used.
Depigmentation is usually accomplished after one to four months of Monobenzone Cream treatment. If satisfactory results are not obtained after four months of Monobenzone Cream treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, monobenzone Cream should be applied only as often as needed to maintain depigmentation (usually only two times weekly).
Monobenzone Cream in 50 g tubes (Net Weight 50 g)
Monobenzone Cream should be stored at 25∼C (77∼F);
excursion permitted to 15∼C - 30∼C (59∼F - 86∼F).