Nova Complex HQ

NOVA COMPLEX HQ- hydroquinone emulsion
Pharma Cosmetics

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Indications & Usage:

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

Skin Bleach

Active Ingrdients

HYDROQUINONE

Keep out of reach of children

Keep out of reach of children

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.
  • 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 because even 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:

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

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.

NEOVA Skin Brightening cream

COMPLEX HQ+
[Hydroquinone, 4%] Skin Brightening cream

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NOVA COMPLEX HQ
hydroquinone emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72251-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (HYDROQUINONE) Hydroquinone 40 mg in 1 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
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72251-005-02 56 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/25/2018
Labeler — Pharma Cosmetics (080622701)
Establishment
Name Address ID/FEI Operations
Sanitor Corporation 797472792 manufacture (72251-005)

Revised: 05/2018 Pharma Cosmetics

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