pigment gel ®

Manufacturer: G.S. COSMECEUTICAL USA, INC.
Effective date: 2011-11-15
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:20

Label at a glance#

ProductPIGMENT

Active ingredientHYDROQUINONE

Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 29.5 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pigment gel^®

PCA skin^®

1 fl oz/1 oz liq/29.5 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199176	hydroquinone 2 % Topical Gel	PSN	1
199176	hydroquinone 0.02 MG/MG Topical Gel	SCD	1
199176	hydroquinone 2 % Topical Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HYDROQUINONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299c	Product name	2	20200213
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
2a856070-cbe7-4f85-be0f-09885ff91196	Product name	1	20150806
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65113-9003-1	2020-01-31	C162847	48780-1	9d75b9d0-6b1d-f424-e053-dadaa90a57ce	pigment gel ®
65113-9003-2	2020-01-31	C162847	48780-1	9d75b9d0-6b1d-f424-e053-dadaa90a57ce	pigment gel ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65113-9003-1	PIGMENT	7.4 mL in 1 BOTTLE, PLASTIC	GEL	7.4		1
65113-9003-2	PIGMENT	29.5 mL in 1 BOTTLE, PUMP	GEL	29.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65113-9003	PIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]	1	2 package rows	20111215_b0bf5462-bd6f-4233-aa03-344532f94271.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
AZELAIC ACID	INACTIVE INGREDIENT	F2VW3D43YT	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
GLUTATHIONE	INACTIVE INGREDIENT	GAN16C9B8O	1
HAMAMELIS VIRGINIANA LEAF WATER	INACTIVE INGREDIENT	8FP93ED6H2	1
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	INACTIVE INGREDIENT	S38J6RZN16	1
KOJIC ACID	INACTIVE INGREDIENT	6K23F1TT52	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	1
PHENYLETHYL RESORCINOL	INACTIVE INGREDIENT	G37UFG162O	1
SILYBUM MARIANUM SEED	INACTIVE INGREDIENT	U946SH95EE	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

PIGMENT
HYDROQUINONE
ALCOHOL
WATER
HAMAMELIS VIRGINIANA LEAF WATER
BUTYLENE GLYCOL
LACTIC ACID
AZELAIC ACID
KOJIC ACID
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)
PHENYLETHYL RESORCINOL
GLUTATHIONE
SILYBUM MARIANUM SEED
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65113-9003	65113-9003-1, 65113-9003-2

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
HYDROQUINONE	XV74C1N1AE	ACTIB
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT
HAMAMELIS VIRGINIANA LEAF WATER	8FP93ED6H2	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
LACTIC ACID	33X04XA5AT	IACT
AZELAIC ACID	F2VW3D43YT	IACT
KOJIC ACID	6K23F1TT52	IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	S38J6RZN16	IACT
PHENYLETHYL RESORCINOL	G37UFG162O	IACT
GLUTATHIONE	GAN16C9B8O	IACT
SILYBUM MARIANUM SEED	U946SH95EE	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CREAM / VAGINAL	0.81 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION, SOLUTION / INTRAVENOUS		87 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	TABLET, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / TOPICAL	0.21 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SYRUP / ORAL	2 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION/ DROPS / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SOLUTION / TOPICAL	7.22 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRACARDIAC	0.01 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / TOPICAL	0.69 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	LOTION / TOPICAL	5.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	CAPSULE / ORAL		132 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SOLUTION / ORAL		192 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / AURICULAR (OTIC)		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ea696aa1-3521-420f-95ec-78e215c1abbc			b0bf5462-bd6f-4233-aa03-344532f94271	2011-11-15		Exact identifier spl id: ea696aa1-3521-420f-95ec-78e215c1abbc spl set id: b0bf5462-bd6f-4233-aa03-344532f94271

Reported adverse events (FAERS/openFDA)#

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