Pigment by Physicians Care Alliance, LLC (d/b/a PCA Skin) Pigment

Pigment by

Drug Labeling and Warnings

Pigment by is a Otc medication manufactured, distributed, or labeled by Physicians Care Alliance, LLC (d/b/a PCA Skin). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PIGMENT- hydroquinone gel 
Physicians Care Alliance, LLC (d/b/a PCA Skin)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pigment

Drug Facts

Active ingredient

Hydroquinone (2%)

Purpose

Skin lightener

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

When using this product

• Avoid contact with the eyes
• Some users of this product may experience a mild skin irritation
• Do not use on children under 12 years of age unless directed by a physician

Stop use and consult a physician if skin irritation becomes severe.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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 should 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

Other information

Store at room temperature (15-30 °C / 59-86 ° F).

Inactive ingredients

Water/Aqua/Eau, Alcohol, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid, Azelaic Acid, Kojic Acid, Phenylethyl Resorcinol, Hydroxyethylcellulose, Sodium Hydroxide, BHT, Glutathione, Silybum Marianum Fruit Extract.

Questions or comments?

877.722.7546

PRINCIPAL DISPLAY PANEL - 29.5 mL Bottle Label

PCA skin®

pigment gel®

℮ 1 fl oz/29.5mL

PIGMENT 
hydroquinone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
AZELAIC ACID (UNII: F2VW3D43YT)
KOJIC ACID (UNII: 6K23F1TT52)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLUTATHIONE (UNII: GAN16C9B8O)
MILK THISTLE (UNII: U946SH95EE)

Product Characteristics
Color	YELLOW (Light yellow, very slightly hazy to clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-900-32	1 in 1 BOX	05/26/2011	01/15/2022
1		29.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 68726-900-31	7.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2011	10/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	05/26/2011	01/15/2022

Labeler - Physicians Care Alliance, LLC (d/b/a PCA Skin) (969945133)

Revised: 8/2020

Document Id: cb295c18-9fb3-4321-80b4-0982ced6e131

34390-5

Set id: 014f337e-d0b1-4505-9b84-0a777913692f

Version: 1

Effective Time: 20200812

 

Physic