NEOVA COMPLEX HQ PLUS- hydroquinone emulsion

Neova by

Drug Labeling and Warnings

Neova by is a Prescription medication manufactured, distributed, or labeled by PhotoMedex, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Complex HQ Plus is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigenes, and other unwanted areas of melanin hyperpigmention.

DIRECTIONS:

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

ACTIVE INGREDIENT:

Hydroquinone, 4%

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.

WARNINGS:

Avoid contact with eyes. Some users may experience mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. In case of accidental ingestion, call a physician or seek a Poison Control Center immediately. Children under 12 years of age: Do not use unless directed by a physician.

KEEP OUT OF REACH OF CHILDREN

FOR EXTERNAL USE ONLY.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

PhotoMedex, Horsham, PA 19044
1.888.966.1010 www.neova.com
Made in the USA

Neova Complex HQ Plus2oz. (56.7 g) label and box

ComplexHQplus2ozLabel.jpg ComplexHQplusBox.jpg

INGREDIENTS AND APPEARANCE

NEOVA  COMPLEX HQ PLUS
hydroquinone emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62362-012
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: 62362-012-01	1 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	Business Operations
PhotoMedex, Inc.		054503875	manufacture(62362-012)