ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone

Manufacturer
ZO Skin Health, Inc.
Effective date
2022-04-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:22

Label at a glance#

ProductZO Skin Health Pigment Control Plus Blending Creme Hydroquinone
Active ingredientHYDROQUINONE
Label structure11 sections

Indications and uses

For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigment in the skin that may occur in pregnancy or from 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 doctor. 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. Children under 12 years of age: do not use unless directed by a doctor. Sun exposure should be limited by using a sunscree...

Storage and handling

Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

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 the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

OTC - DO NOT USE SECTION

Do not use on children under 12 years of age unless directed by a doctor.

OTC - STOP USE SECTION

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, seek 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 doctor. 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.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Other Information

STORAGE AND HANDLING SECTION

  • Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract

Questions?

OTC - QUESTIONS SECTION

5 Technology Dr. Irvine, CA 92618

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-039-80

PIGMENT CONTROL +
BLENDING CRÈME
2% Hydroquinone

80 mL / 2.7 Fl. Oz.

Principal Display Panel - 80 mL Bottle Carton
Principal Display Panel - 80 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244594hydroquinone 2 % Topical LotionPSN2
244594hydroquinone 20 MG/ML Topical LotionSCD2
244594hydroquinone 2 % Topical LotionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-039-802024-01-30C16284748780-11030e365-2bc4-111a-e063-dadaa90a10e2ZO ® Skin Health Pigment Control + Blending Crème 2% Hydroquinone National Drug Code 42851-039-80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-039-80ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone1 in 1 CARTONLOTION12
42851-039-80ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone80 mL in 1 BOTTLE, PLASTICLOTION802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-039ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE (HYDROQUINONE) LOTION [ZO SKIN HEALTH, INC.]2Legacy NDC, 2 package rows20220427_92dc0786-083b-4c5a-8bea-dc2d5a391b10.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-03942851-039-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
dd83ff60-1948-7743-e053-2995a90aab3192dc0786-083b-4c5a-8bea-dc2d5a391b102022-04-25WarningsExact identifier
spl id: dd83ff60-1948-7743-e053-2995a90aab31
spl set id: 92dc0786-083b-4c5a-8bea-dc2d5a391b10

Reported adverse events (FAERS/openFDA)#

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