Download Aclaro® (hydroquinone USP 4%) emulsion For External Use Only

Aclaro® (hydroquinone USP 4%) emulsion
For External Use Only
Rx Only
a
B.
al
Description: Hydroquinone is 1,4-benzenediol. Hydroquinone is structurally related to
monobenzone. Hydroquinone occurs as
fine, white needles. The drug is freely soluble in water and in alcohol with a pKa of
9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2 ; molecular weight 110.1. The
structural formula is:
resulting rom the use of oral contraceptives,
pregnancy, hormone OH
replacment therapy, or
skin trauma.
Contraindications: Aclaro® is contraindicated in any patient that has a prior history
of hypersensitivity orOH
allergic reaction to
hContents:
ydroquinone or any of the other ingredients.
The
safety of topical
hydroquinone
Active
Ingredients:
hydroquinone
USP 4%
use
during
pregnancy
or on children
(12
Other
Ingredients:
ascorbic
acid, benzyl
yalcohol,
ears and
under)
has
not
been
established.
butyl methoxydibenzoylmethane,
C12-15 alkyl benzoate, cetearyl octanoate,
Wa
rnings:
cetyl
alcohol, cetyl esters, cetyl palmitate,
A.
Caution:
Hydroquinone
is a depigmentDEA
cetyl phosphate,
dimethicone,
disodium
ing
agent
which may
produce unwanted
EDTA,
ethylhexyl
methoxycinnamate,
glyccosmetic
effects
not used asglycolate,
directed.
erin, glycolic
acid,if ammonium
The
physician should be
familiar with the
hydroxyethylcellulose,
phenoxyethanol,
puricontents
ofsodium
this insert
before prescribing
or
fied water,
metabisulfite,
and stearic
dispensing
this medication.
acid.
B. Test for skin sensitivity before using
Aclaro®
4%)application
emulsion
Clinical (hydroquinone
Pharmacology:USP
Topical
by
a small
amounta to
an unbroken
of applying
hydroquinone
produces
reversible
patch
of skin andofcheck
within
24 hours.of
depigmentation
the skin
by inhibition
Minor
redness oxidation
is not a contraindication,
the enzymatic
of tyrosine to 3- but
(3,41
where
there is itching,
vesicle
formation,
and sup-or
dihydroxyphenyl)
alanine
(dopa)
epression
xcessiveofinflammatory
response,
further
other melanocyte
metabolic
treatment
processes.is2 not advised. Close patient
supervision is recommended. Contact with
avoided.
If no lightening
the
eyes should
Indications
andbe
Usage:
Aclaro®
is indicateffect
noted
aftertreatment
two months
of treated foristhe
gradual
of ultraviolet
ment,
use
of
Aclaro®
emulsion
should
induced dyschromia and discoloration be
discontinued.
resulting rom the use of oral contraceptives,
C.
Sunscreen
use is an
essential aspect
pregnancy,
hormone
replacment
therapy,ofor
hskin
ydroquinone
trauma. therapy because even minimal sunlight exposure sustains melanocyte
activity.
During and after
the use
of Aclaro®
Contraindications:
Aclaro®
is contraindiemulsion,
sunpatient
exposure
be history
cated in any
thatshould
has a prior
limited
or sun-protective
clothing
should
of hypersensitivity
or allergic
reaction
to be
used
to cover the
treated
areas
toingrediprevent
hydroquinone
or any
of the
other
repigmentation.
ents. The safety of topical hydroquinone
D.
Keep
thispregnancy
and all medications
out of(12
the
use
during
or on children
reach
children.
case
accidental
years of
and
under) In
has
notof
been
established.
ingestion, contact a physician or a poison
control
center immediately.
Warnings:
A. Caution: Hydroquinone is a depigmenting 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.
B. Test for skin sensitivity before using
Aclaro® (hydroquinone USP 4%) emulsion
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, vesicle formation, or
excessive inflammatory response, further
treatment is not advised. Close patient
supervision is recommended. Contact with
the eyes should be avoided. If no lightening
effect is noted after two months of treatment, use of Aclaro® emulsion should be
treatment is not advised. Close patient
supervision is recommended. Contact with
the eyes should be avoided. If no lightening
effect is noted after two months of treatment, use of Aclaro® emulsion should be
discontinued.
C. Sunscreen use is an essential aspect of
hydroquinone therapy because even minimal sunlight exposure sustains melanocyte
activity. During and after the use of Aclaro®
emulsion, sun exposure should be
limited or sun-protective clothing should be
used to cover the treated areas to prevent
repigmentation.
D. Keep this and all medications out of the
reach of children. In case of accidental
ingestion, contact a physician or a poison
control center immediately.
E. On rare occasions, a gradual blue-black
darkening of the skin may occur. If this
occurs, the product should be discontinued
and a physician contacted immediately.
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 affect reproductive capacity.
It is not known to what degree, if any, topical hydroquinone is absorbed systemically.
Topical hydroquinone should be used in
pregnant 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
hydroquinone is used by a nursing mother.
C. Pediatric usage: Safety and effectiveness
in pediatric patients below the age of 12
years have not been established.
have
beenairless
reported.
Occasional
cutaneous
1.7
ounce
pump
bottle
hypersensitivity
(localized contact dermatitis)
NDC
68712-003-01
may occur, in which case the medication
should be discontinued and the physician
References:
1.notified
Dentonimmediately.
C., Lerner A.B., and Fitzpatrick T.B.
"Inhibition
Melanin Formation
by Chemical
Warning:ofContains
sodium metabisulfite,
Agents."
ofcause
Investigative
a sulfiteJournal
that may
serious allergic
Dermatology.
1952;18:119
- 135.
reactions (e.g.,
hives, itching,
wheezing,
2.anaphylaxis,
Jimbow K., Obata
Pathak
M., and
severeH.,
asthma
attack)
in cerFitzpatrick
T.B. "Mechanism
tain susceptible
persons. of
Depigmentation by Hydroquinone." Journal
There have been
no systemic
ofOverdosage:
Investigative Dermatology.
1974;62:436
reactions reported from the use of topical
449.
hydroquinone. However, treatment should
be limited
to relatively
areas of the
Store
at controlled
roomsmall
temperature:
body
at C
one
time,
since
F) some patients expe15˚
- 30˚
(59˚
– 86˚
rience a transient skin reddening and a mild
burning sensation
Manufactured
for: which does not preclude
treatment.
Innocutis
a JSJ Pharmaceuticals company
Charleston, SC 29401
www.Aclaro4.com
www.Innocutis.com
March 2010
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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.
E. On rare Contains
occasions,
a gradual
blue-black
Warning:
sodium
metabisulfite,
the skin
may
occur.allergic
If this
adarkening
sulfite thatofmay
cause
serious
occurs, the
product
bewheezing,
discontinued
reactions
(e.g.,
hives,should
itching,
and a physician
contacted
anaphylaxis,
severe
asthmaimmediately.
attack) in certain susceptible persons.
Precautions: See Warnings
Overdosage:
haveC:been
no systemic
A. PregnancyThere
Category
Animal
reproreactions
reported
from
useconducted
of topical
duction studies
have
notthe
been
hwith
ydroquinone.
However, treatment
topical hydroquinone.
It is alsoshould
not
be
limited
to relatively
small areas
the
known
whether
hydroquinone
canofcause
body
at
one
time,
since
some
patients
expefetal harm when used topically on a pregrnant
iencewoman
a transient
skin reproductive
reddening and
a mild
or affect
capacity.
bu
rning
whichdegree,
does not
preclude
It is
not sensation
known to what
if any,
topitreatment.
cal hydroquinone is absorbed systemically.
Topical hydroquinone
should be
used in
Dosage
and Administration:
Aclaro®
pregnantshould
womenbeonly
whentoclearly
indicatemulsion
applied
the affected
ed. twice daily, or as directed by a physiareas
B. Nursing
It is not known
whether
cian.
There ismothers:
no recommended
dosage
for
topical hydroquinone
absorbed
excretpediatric
patients underis12
years ofor
age
in human
milk.
Caution
advised when
eed
xcept
under the
advice
andissupervision
of a
hydroquinone is used by a nursing mother.
physician.
C. Pediatric usage: Safety and effectiveness
in pediatric
patients below the age of 12
How
Supplied:
years have not been established.
Aclaro® (hydroquinone USP 4%) emulsion
isAdverse
availableReactions:
as follows: No systemic reactions
have been reported. Occasional cutaneous
hypersensitivity
contact dermatitis)
1.7
ounce airless(localized
pump bottle
may occur,
in which case the medication
NDC
68712-003-01
should be discontinued and the physician
notified immediately.
References:
m
st
Aclaro® (hydroquinone USP 4%) emulsion
For External Use Only
Rx Only
Description: Hydroquinone is 1,4-benzenediol. Hydroquinone is structurally related to
monobenzone. Hydroquinone occurs as
fine, white needles. The drug is freely soluble in water and in alcohol with a pKa of
9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2 ; molecular weight 110.1. The
structural formula is:
OH