Search by Drug Name or NDC
NDC 72251-0005-02 Nova Complex HQ 40 mg/g Details
Nova Complex HQ 40 mg/g
Nova Complex HQ is a TOPICAL EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pharma Cosmetics. The primary component is HYDROQUINONE.
Product Information
NDC | 72251-0005 |
---|---|
Product ID | 72251-005_ebf0e8fb-7ff8-2a26-e053-2a95a90a1180 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Nova Complex HQ |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Hydroquinone |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | EMULSION |
Route | TOPICAL |
Active Ingredient Strength | 40 |
Active Ingredient Units | mg/g |
Substance Name | HYDROQUINONE |
Labeler Name | Pharma Cosmetics |
Pharmaceutical Class | Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | n/a |
Package
Package Images


NDC 72251-0005-02 (72251000502)
NDC Package Code | 72251-005-02 |
---|---|
Billing NDC | 72251000502 |
Package | 56 g in 1 BOTTLE (72251-005-02) |
Marketing Start Date | 2018-04-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5c4ea0c9-6b61-4e2c-97cd-60fd9b46e47c Details
Indications & Usage:
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
INGREDIENTS AND APPEARANCE
NOVA COMPLEX HQ
hydroquinone emulsion |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
Labeler - Pharma Cosmetics (080622701) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Sanitor Corporation | 797472792 | manufacture(72251-005) |