African Formula Black

Manufacturer: International Beauty Exchange | JABONES PARDO SA
Effective date: 2011-03-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:36

Label at a glance#

ProductAfrican Formula Black

Active ingredientHYDROQUINONE

Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

WARNINGS SECTION

For external use only

OTC - PURPOSE SECTION

Skin Lightener

OTC - DO NOT USE SECTION

On children under 12 years of age unless directed by a doctor

OTC - WHEN USING SECTION

Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of product

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66129-102-31	2019-10-29	C162847	48780-1	960f7f55-d322-8e05-e053-dbdaa90a074a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66129-102-31	African Formula Black	50 g in 1 TUBE	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66129-102	AFRICAN FORMULA BLACK (HYDROQUINONE) CREAM [INTERNATIONAL BEAUTY EXCHANGE]	1	Legacy NDC, 1 package rows	20110330_b7b897f5-37ea-4f4d-9247-e1226c0c1217.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

African Formula Black
Hydroquinone
WATER
ALCOHOL
GLYCERIN
CARBOMER COPOLYMER TYPE A
COCOA BUTTER
.ALPHA.-TOCOPHEROL ACETATE, D-
ASCORBIC ACID
SODIUM METABISULFITE
EDETATE DISODIUM
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66129-102	66129-102-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROQUINONE	XV74C1N1AE	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER COPOLYMER TYPE A	71DD5V995L	IACT
COCOA BUTTER	512OYT1CRR	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
EDETATE DISODIUM	7FLD91C86K	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 6 · 314 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / ORAL	8 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBCUTANEOUS		43 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / PERINEURAL	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		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
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 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 / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRACARDIAC	0.09 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	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
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CONCENTRATE / ORAL	2 mg/1ml		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CONCENTRATE / ORAL	6 mg/1ml		Exact identifier — unii candidate 25 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
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET, ORALLY DISINTEGRATING / ORAL	2.35 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 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
e7d9b1c6-baf0-4f26-85de-16ea23283ebd			b7b897f5-37ea-4f4d-9247-e1226c0c1217	2011-03-29	Warnings	Exact identifier spl id: e7d9b1c6-baf0-4f26-85de-16ea23283ebd spl set id: b7b897f5-37ea-4f4d-9247-e1226c0c1217

Reported adverse events (FAERS/openFDA)#

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