FDA Label for Balancer

Other

RX Only

FOR EXTERNAL USE ONLY

Distributed By

Axia Medical Solutions     Carlsbad, California 92011

Description

DERMESSE BALANCER contains: Hydroquinone 40mg/gm.  See label on bottle for complete list of ingredients.  Following is its chemical structure:

Chemical Structure - structure

Clinical Pharmacology

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.

Indications And Usage

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.

Contraindications

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.

Warnings

• CAUTION: Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
• Test for skin sensitivity before using Hydroquinone Cream by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching and vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician.  A bitter taste and anesthetic effect may occur if applied to lips.  Keep out of reach of children.  If no bleaching or lightening effect is noted after 2 months of treatment use, Hydroquinone Creamshould be discontinued. This productis formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.
• Sunscreen use is an essential aspect of Hydroquinone therapy because even minimal sunlight sustains melanocytic activity.  After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent, or protective clothing to prevent repigmentation.  There are no sunblocking or sunscreening agents in DERMESSE BALANCER and since minimal sunlight exposure may reverse the bleaching effect of this preparation.  It should be used only at night or on areas of the body covered by protective clothing.  During the daytime, sunblocking or broad spectrum sunscreen preparations or protective clothing should be used to prevent the bleached areas from repigmentation.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Warning: Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.

Precautions

See Warnings

A. Pregnancy Category C

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.

B. Nursing Mothers

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.

C. Pediatric Usage

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

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

Overdosage

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.

Drug Dosage And Adminstration

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.

How Supplied

DERMESSE BALANCER is available as follows:

2 Oz. (57g) bottle

Storage And Handling

DERMESSE BALANCER should be stored at controlled room temperature (15°-30°C) (59°-86°F).  Darkening of this product is normal.  This will not affect performance or safety.

Package Label.Principal Display Panel

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