Skin Lightening

Manufacturer: Rodan & Fields, LLC. | Cosmetic Enterprises Ltd
Effective date: 2012-01-24
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:30:43

Label at a glance#

ProductSkin Lightening Rodan Fields

Active ingredientHYDROQUINONE

Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

OTC - PURPOSE SECTION

Skin Lightening

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

if swallowed, get medical help or contact a poison control center immediately.

WARNINGS SECTION

avoid contact with eyes.

some user of this product may experience a mild skin irritation. if skin irritation becomes severe , stop use and consult a physician.

do not use if pregnant or nursing.

do not use on children under 12 years of age unless directed by a physician.

DOSAGE & ADMINISTRATION SECTION

apply evenly to the entire face with a fresh gauze pad, avoiding the eye area. do not rinse off, allow to dry. use once daily and increase to twice daily as tolerated.

Adult: apply a small amount as a think layer in affected area once or twice daily, or use as directed by a physician . if no improvement is seen after three 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.

children under 12 years of age: do not use unless directed by a physician.

INACTIVE INGREDIENT SECTION

Water (aqua), Ethoxydiglycol, Hamamelis Virgiana ( Witch Hazel) Water, Methylpropanediol, Alcohol Denat, Polysorbate 20, Butylene Glycol, Aminopropyl Ascorbyl Phosphate, Foeniculum Vulgare ( Fennel) Seed Extract, Magnesium Ascorbyl Phosphate, Arctostaphylos Uva Ursi (leaf) Extract, PEG-12, Dimethicone, Arnica Montana Flower Extract, Zinc Phenolsulfonate, Kojic Acid, Citrus Medica Limonum ( Lemon) Peel Extract, Sodium Salicylate, Citric Acid, Sodium Sulfite, Sodium Metabisulfite, DMDM Hydantoin, Fragrance, Yellow 5, Yellow 6

image of box

INDICATIONS & USAGE SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan and Fields

Reverse

Dermatologist developed skin lightening toner

125 mL/ 4.2 Fl. Oz.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1042620	hydroquinone 2 % Topical Solution	PSN	4
1042620	hydroquinone 20 MG/ML Topical Solution	SCD	4
1042620	hydroquinone 2 % Topical Solution	SY	4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0884164002250	GTIN-13: 0884164002250 EAN-13: 0884164002250 GTIN-12: 884164002250 UPC-A: 884164002250 GTIN storage (14 digits): 00884164002250	box.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
14222-1615-2	2019-11-13	C162847	48780-1	97449f38-d11b-f6ea-e053-dbdaa90aa703	Rodan and Fields Reverse 2 Skin Toner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14222-1615-1	Skin LighteningRodan Fields	125 mL in 1 TUBE	LIQUID	125		4
14222-1615-2	Skin LighteningRodan Fields	1 in 1 BOX	LIQUID	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14222-1615	SKIN LIGHTENING RODAN FIELDS (HYDROQUINONE) LIQUID [RODAN & FIELDS, LLC.]	4	Legacy NDC, 2 package rows	20120124_7a5faa65-5132-4e36-8c11-fbb91bb8b275.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	4
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	4
ARCTOSTAPHYLOS UVA-URSI LEAF	INACTIVE INGREDIENT	3M5V3D1X36	4
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	4
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	4
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	4
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	4
FENNEL SEED	INACTIVE INGREDIENT	G3QC02NIE6	4
KOJIC ACID	INACTIVE INGREDIENT	6K23F1TT52	4
LEMON PEEL	INACTIVE INGREDIENT	72O054U628	4
MAGNESIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	0R822556M5	4
METHYLPROPANEDIOL	INACTIVE INGREDIENT	N8F53B3R4R	4
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	4
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	4
SODIUM SALICYLATE	INACTIVE INGREDIENT	WIQ1H85SYP	4
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	4
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	4
ZINC PHENOLSULFONATE	INACTIVE INGREDIENT	4O71YT5YB5	4

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Skin Lightening Rodan Fields
HYDROQUINONE
DIETHYLENE GLYCOL MONOETHYL ETHER
WITCH HAZEL
METHYLPROPANEDIOL
POLYSORBATE 20
BUTYLENE GLYCOL
FENNEL SEED
MAGNESIUM ASCORBYL PHOSPHATE
ARCTOSTAPHYLOS UVA-URSI LEAF
POLYETHYLENE GLYCOL 600
DIMETHICONE
ARNICA MONTANA FLOWER
ZINC PHENOLSULFONATE
KOJIC ACID
LEMON PEEL
SODIUM SALICYLATE
SODIUM SULFITE
SODIUM METABISULFITE
DMDM HYDANTOIN
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
14222-1615	14222-1615-1, 14222-1615-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROQUINONE	XV74C1N1AE	ACTIB
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
WITCH HAZEL	101I4J0U34	IACT
METHYLPROPANEDIOL	N8F53B3R4R	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
FENNEL SEED	G3QC02NIE6	IACT
MAGNESIUM ASCORBYL PHOSPHATE	0R822556M5	IACT
ARCTOSTAPHYLOS UVA-URSI LEAF	3M5V3D1X36	IACT
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
DIMETHICONE	92RU3N3Y1O	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
ZINC PHENOLSULFONATE	4O71YT5YB5	IACT
KOJIC ACID	6K23F1TT52	IACT
LEMON PEEL	72O054U628	IACT
SODIUM SALICYLATE	WIQ1H85SYP	IACT
SODIUM SULFITE	VTK01UQK3G	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C YELLOW NO. 6	H77VEI93A8	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 · 163 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / ORAL	8 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	CAPSULE / ORAL	0.5 mg		Exact identifier — unii candidate 18 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
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION / SOFT TISSUE		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE, LIQUID FILLED / ORAL		1584 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INFILTRATION	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LIQUID / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION, SOLUTION / INTRAVENOUS		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 28 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
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CAPSULE / ORAL	0.36 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	TABLET / ORAL	5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION/ DROPS / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / IONTOPHORESIS	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / BUCCAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION / INTRALESIONAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION, SOLUTION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 9 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
c6954fc7-c178-41e7-895d-5b71f8f9b657			7a5faa65-5132-4e36-8c11-fbb91bb8b275	2012-01-24	Warnings	Exact identifier spl id: c6954fc7-c178-41e7-895d-5b71f8f9b657 spl set id: 7a5faa65-5132-4e36-8c11-fbb91bb8b275

Reported adverse events (FAERS/openFDA)#

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