NOVA COMPLEX HQ- hydroquinone emulsion

Nova Complex HQ by

Drug Labeling and Warnings

Nova Complex HQ by is a Prescription medication manufactured, distributed, or labeled by Pharma Cosmetics, Sanitor Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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:

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, StearylAlcohol, Vitamin E Acetate.

NEOVASkin Brightening cream

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

INGREDIENTS AND APPEARANCE

NOVA COMPLEX HQ 
hydroquinone emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72251-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	Hydroquinone	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Ascorbic Acid (UNII: PQ6CK8PD0R)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Cetyl Alcohol (UNII: 936JST6JCN)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Glycolic Acid (UNII: 0WT12SX38S)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72251-005-02	56 g in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2018

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	Business Operations
Sanitor Corporation		797472792	manufacture(72251-005)