Pigment

Manufacturer
Physicians Care Alliance, LLC (d/b/a PCA Skin)
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:09

Label at a glance#

ProductPigment
Active ingredientHYDROQUINONE
Label structure10 sections

Indications and 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.

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone (2%)

Purpose

OTC - PURPOSE SECTION

Skin lightener

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

877.722.7546

PRINCIPAL DISPLAY PANEL - 29.5 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCA skin®

pigment gel®

℮ 1 fl oz/29.5mL

PRINCIPAL DISPLAY PANEL - 29.5 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 29.5 mL Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-90068726-900-32, 68726-900-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cb295c18-9fb3-4321-80b4-0982ced6e131014f337e-d0b1-4505-9b84-0a777913692f2020-08-12WarningsExact identifier
spl id: cb295c18-9fb3-4321-80b4-0982ced6e131
spl set id: 014f337e-d0b1-4505-9b84-0a777913692f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.