Nova Complex HQ

Manufacturer
Pharma Cosmetics | Sanitor Corporation
Effective date
2022-10-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:50:24

Label at a glance#

ProductNova Complex HQ
Active ingredientHYDROQUINONE
Label structure8 sections

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 productshould 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. DNA Damage ControlTM [EVERYDAY | BROAD SPECTRUM SPF 44] or other broad spectrum sunscreen or protective cloth...

Label contents#

Full prescribing information#

Indications & Usage:

INDICATIONS & USAGE SECTION

COMPLEX HQ+ 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+ treatment.

Purpose  

OTC - PURPOSE SECTION

Skin Bleach

Active Ingrdients  

OTC - ACTIVE INGREDIENT SECTION

HYDROQUINONE

Keep out of reach of children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

  • 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.
  • Test for skin sensitivity before using Hydroquinone Cream by applying asmall amount to an unbroken patch of skin and check in 24 hours. Minorredness is not a contraindication, but where there is itching or vesicleformation or excessive inflammatory response, further treatment is notadvised. Close patient supervision is recommended.Contact with the eyes should be avoided. In case of accidental contact, pa-

    tient 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 oftreatment use, Hydroquinone Cream should be discontinued. This product isformulated 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 becauseeven minimal sunlight exposure sustains melanocytic activity. After clear-ing 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+ 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 this and all medications out of the reach of children. In case of ac-cidental ingestion, call a physician or a poison control center immediately.

  • 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.

Drug Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer on the skin surface in  the affected areas twice a day or as directed by physician. Use of this productshould 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. DNA Damage ControlTM [EVERYDAY | BROAD SPECTRUM SPF 44] or other broad spectrum sunscreen or protective clothing should be used to prevent reoccurring hyperpigmentation.

Inactive Ingridients

INACTIVE INGREDIENT SECTION

Ascorbic Acid, Butylated Hydroxytoluene, Cetyl Alcohol, Edetate Disodium, Fragrance, Glycerin, Glycolic Acid, Methylparaben, Propyl-

paraben, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, Stearyl Alcohol, Vitamin E Acetate.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label-1Product label-1Product label-2Product label-2

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72251-00572251-005-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ebf0e8fb-7ff8-2a26-e053-2a95a90a11805c4ea0c9-6b61-4e2c-97cd-60fd9b46e47c2022-10-26WarningsExact identifier
spl id: ebf0e8fb-7ff8-2a26-e053-2a95a90a1180
spl set id: 5c4ea0c9-6b61-4e2c-97cd-60fd9b46e47c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.