Dosage Form: topical emulsion
Complex HQ Plus - Hydroquinone 4% - 56g - 2.0 oz. - RX only - package insert
Rx only
For External Use Only.
Description
Complex HQplus contains: Hydroquinone 40 mg/gm.
Active Ingredient
Hydroquinone, 4%
Clinical Pharmacology:
Topical application of Hydroquinone produces
a reversible depigmentation of the skin by inhibition of the enzymatic
oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and
suppression of other melanocyte 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 repigmentation
of the bleached areas, which may be prevented by the use of
sunblocking agents.
Indications & Usage:
Complex HQ Plus is indicated for the gradual
lightening of hyperpigmented skin conditions, such as chloasma,
melasma, freckles, senile lentigines, and other unwanted areas of
melanin hyperpigmentation. Sunscreen must be used daily during
Complex HQ Plus treatment.
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
A. 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.
B. Test for skin sensitivity before using Hydroquinone 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. 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 Cream should be discontinued. This product is
formulated for use as a skin bleaching agent and should not be
used for the prevention of sunburn.
C. Sunscreen use is an essential aspect of Hydroquinone therapy
because even minimal sunlight exposure 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 Complex
HQ plus 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.
D. Keep this and all medications out of the reach of children. In
case of accidental ingestion, call a physician or a poison control
center immediately.
E. Warning: Contains sodium metabisulfite, a sulfite that may
cause serious allergic type reactions (e.g. hives, itching,
wheezing, anaphylaxis, severe asthma attacks) 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 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.
Over Dosage:
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 a transient skin reddening and a mild burning sensation
which does not preclude treatment.
Drug Dosage and Administration:
Apply a thin layer on the skin
surface in the affected areas twice a day or as directed by
physician. Use of this product should be discontinued after
3 months of treatment if no improvement is observed. The lightening
effect may not be noticeable when used on very dark skin. Sun
exposure should be avoided. Ti-Silc Sheer SPF 45 or other broad
spectrum sunblock or protective clothing should be used to prevent
reoccurring hyperpigmentation.
Storage:
Complex HQ Plus 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.
Supplied
as a 2oz. (56.7 grm) bottle, NDC 62362-012-02
Inactive Ingredients:
Ascorbic Acid, Butylated Hydroxytoluene,
Cetyl Alcohol, Edetate Disodium, Fragrance, Glycerin, Glycolic Acid,
Methylparaben, Propylparaben, Purified Water, Sodium Lauryl Sulfate,
Sodium Metabisulfite, Stearyl Alcohol, Vitamin E Acetate.
Image of Label, Box, and Package Insert
ComplexHQplus2ozLabel.jpg
| NEOVA Complex HQ Plus hydroquinone emulsion | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/09/2012 | ||
| Labeler - PhotoMedex, Inc. (054503875) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| PhotoMedex, Inc. | 054503875 | manufacture | |
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