Neova Complex HQ Plus

NEOVA COMPLEX HQ PLUS- hydroquinone emulsion
PhotoMedex, Inc.

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.

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.

FOR EXTERNAL USE ONLY.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

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

Neova Complex HQ Plus 2oz. (56.7 g) label and box

ComplexHQplus2ozLabel.jpg

label
(click image for full-size original)
box
(click image for full-size original)

NEOVA COMPLEX HQ PLUS
hydroquinone emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62362-012
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:62362-012-01 1 BOTTLE in 1 BOX contains a BOTTLE (62362-012-02)
1 NDC:62362-012-02 56 g in 1 BOTTLE This package is contained within the BOX (62362-012-01)
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 Operations
PhotoMedex, Inc. 054503875 manufacture (62362-012)

Revised: 01/2014 PhotoMedex, Inc.

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