BALANCER- hydroquinone cream
Axia Medical Solutions, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
DERMESSE BALANCER contains: Hydroquinone 40mg/gm. See label on bottle for complete list of ingredients. Following is its chemical structure:
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes.
The selective inhibition of the enzyme affects melanogenesis in the melanocytes resulting in cessation of melanin formation and subsequent reduction in pigmentation. Additional studies indicate Hydroquinone acts on the essential subcellular metabolic processes of melanocytes with resultant cytolysis, i.e. nonenzymediated depigmentation.
Exposure to sunlight or ultraviolet light will cause regimentation of the bleached areas, which may be prevented by the use of sunblocking agents.
DERMESSE BALANCER is indicated for the gradual bleaching of hyperpigmented skin conditions such as chlosma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.
Animal reproduction studies have not been conducted with topical Hydroquinone. It is also not known whether Hydroquinone can cause fetal harm when used topically on a pregnant woman or can affect reproductive capacity. It is not known to what degree, if any, topical Hydroquinone is absorbed systemically. Topical Hydroquinone should be used in women only when clearly indicated.
It is not known whether topical Hydroquinone is absorbed or excreted in human milk. Caution is advised when topical Hydroquinone is used by a nursing mother.
No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately
There have been no systemic reactions reported from the use of topical Hydroquinone. However, treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.
A thin application of DERMESSE BALANCER should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under the age of 12 years of age except under the advice and supervision of a physician.
DERMESSE BALANCER is available as follows:
2 Oz. (57g) bottle
|Labeler - Axia Medical Solutions, LLC (929224694)|
|Axia Medical Solutions, LLC||929224694||manufacture(68723-143)|