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 Melashine
Cream
Ingredient(s)
Each gram contains:
Hydroquinone ................. 40
mg
Preservative(s)
Each gram contains:
Methyl Paraben ................ 1
mg
Propyl Paraben .............. 0.5
mg
Pharmacology (Summary of
Pharmacodynamic and Pharmacokinetics)
Topical application of
hydroquinone produces a reversible depigmentation of the skin by inhibition
of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine and
suppression of other melanocyte metabolic processes.
It may be several weeks before
any effect is apparent but depigmentation may last for 2 - 6 months after
discontinuation.
Indications(s)
Melashine cream 4% is used
topically as a depigmenting agent for the skin in hyperpigmentation
conditions such as chloasma (melasma), freckles, and lentigines (small
macules that resemble freckles).
Dosage and Administration
Melashine cream 4% should be
applied twice daily to intact skin. Application should be discontinued fi
there is no improvement after 2 months of application.
To be applied onto the skin.
Contraindications(s)
Hypersensitivity or allergic
reaction to this product or any of its ingredients.
Precaution(s)/Warning(s)
Melashine cream 4% may cause
transient erythema and a mild burning sensation. High concentrations or
prolonged use may lead to hyperpigmentation especially on areas of skin
exposed to sunlight. Avoid solar exposure. Stop use if skin irritation
occurs.
Melashine cream 4% should not be
applied to abrade or sun burnt skin. It should not be used to bleach
eyelashes or eye brows and contact with the eyes should be avoided as it may
produce staining and corneal opacities.
Hydroquinone is a skin bleaching
agent which may produce unwanted cosmetic effects if not used as directed.
Test for skin sensitivity before using Melashine Cream by applying a small
amount to an unbroken patch of skin and check in 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. Close
patient supervision is recommended. Contact with the eyes should be avoided.
Melashine cream is formulated for use as a skin bleaching agent and should
not be used for the prevention of sunburn. The safety of topical
hydroquinone use during pregnancy, in nursing mothers or in children (12
years and under) has not been established.
Users are advice to either use
a sunscreening agent or protect themselves from sunlight or to use the
products only at night.
Interaction with Other
Medicaments
No related information has been
reported.
Pregnancy and Lactation
FDA 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 use
topically on a pregnant woman or affect reproductive capacity. It is not
known to what degree, if any, topical hydroquinone is absorbed systemically.
Topical hydroquinone should be used by pregnant 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.
Side Effect(s)/Adverse
Reactions
No systemic adverse reactions
have been reported. Occasionally hypersensitivity has occurred. Hence, it is
recommended to do skin testing before use. Ochronosis usually becomes
apparent after about 6 months application of hydroquinone and, once
established, is probably irreversible. Reversible brown discoloration of the
nails has also been reported.
Symptoms and Treatment for
Overdosage, and Antidote(s)
There have been no systemic
reactions 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 transient skin reddening and a mild burning sensation
which does not preclude treatment.
Shelf-Life
3 years from the date of
manufacture.
Storage Condition(s)
Keep in an airtight container.
Store at temperature below 25°C. Protect from light and moisture.
Product Description &
Packing(s)
A white cream.
Aluminium tube of 20 g
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