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Pigment

CoValence Inc.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient:  Hydroquinone (2%)

Purpose

Purpose:  Skin Lightener

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

Uses:  For gradual fading of discolorations of the skin such as freckles, age and liver spots, pigment in the skin that may occur from pregnancy or the use of oral contraceptives.

Warnings:  For external use only. Stop use and consult a physician if skin irritation becomes severe. 

Directions:  Adults:  Apply a small amount as a thin layer on the affected area twice daily or use as directed by a physician.  If no improvement is seen after 3 months of treatment, use of this product sould be discontinued.  Lightening effect of this product may not be noticeable when used on very dark skin.  Sun exposure should be limited by using a sunscreen agent or protective clothing when using or after using this product in order to prevent darkening from reoccurring.

Inactive Ingredients:  Hamamelis Virginiana (Witch Hazel) Water, Alcohol Denat., Water/Aqua/Eau, Propylene Glycol, Lactic Acid, Azelaic Acid, Kojic Acid, Citric Acid, Hydroxypropyl Methylcellulose.

Principal Display Panel:  Pigment

Pigment

Hydroquinone GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66915-113
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydroquinone HYDROQUINONE 20 mg

Inactive Ingredients

Ingredient Name Strength
HAMAMELIS VIRGINIANA LEAF WATER
ALCOHOL
water
propylene glycol
LACTIC ACID
Azelaic Acid
KOJIC ACID
CITRIC ACID MONOHYDRATE
HYPROMELLOSE 2208 (4000 MPA.S)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66915-113-01 30 in 1 BOTTLE, GLASS
2 NDC:66915-113-02 7 in 1 JAR
3 NDC:66915-113-03 2000000 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part358A 2011-08-22


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