Complex HQ Plus

Name: Complex HQ Plus

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.

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 ComplexHQplusBox.jpg PkgInsertComplexHQpluspg1.jpg PkgInsertComplexHQpluspg2.jpg

NEOVA  Complex HQ Plus
hydroquinone emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62362-012
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
Ascorbic Acid  
Butylated Hydroxytoluene  
Cetyl Alcohol  
Edetate Disodium  
Glycerin  
Glycolic Acid  
Methylparaben  
Propylparaben  
Water  
Sodium Lauryl Sulfate  
Sodium Metabisulfite  
Stearyl Alcohol  
Vitamin E Acetate  
Packaging
# Item Code Package Description
1 NDC:62362-012-01 1 BOTTLE (BOTTLE) in 1 BOX
1 NDC:62362-012-02 56 g in 1 BOTTLE
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
Revised: 01/2012   PhotoMedex, Inc.

For Healthcare Professionals

Applies to hydroquinone topical: compounding powder, topical cream, topical emulsion, topical gel, topical solution

Dermatologic

Dermatologic side effects have included localized contact dermatitis. Exogenous ochronosis (involving over 10,000 exposures under careful clinical supervision) has been reported at an incidence of 22 cases in more than 50 years.[Ref]

Some side effects of Complex HQ Plus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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