Indications and uses
For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigments in the skin that may occur in pregnancy or from the use of oral contraceptives.
ZO Skin Health Pigment Control 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 23:49:21
Label at a glance#
ProductZO Skin Health Pigment Control Creme Hydroquinone
Active ingredientHYDROQUINONE
Label structure11 sections
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
Hydroquinone, 2%
Purpose
Skin Bleaching Agent
Uses
For the gradual fading of (or lightens) dark (or brownish) discolorations in the skin such as freckles, age spots, pigments in the skin that may occur in pregnancy or from the use of oral contraceptives.
Warnings
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
- 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
- Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Inactive Ingredients
Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, 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?
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
ZO
® SKIN HEALTH
BY ZEIN OBAGI MD
NDC 42851-038-80
PIGMENT CONTROL
CRÈME
2% Hydroquinone
80 mL / 2.7 Fl. Oz. U.S.
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROQUINONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42851-038-80 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6aa8-d83d-e063-dadaa90ab31f | ZO ® Skin Health Pigment Control Creme 2% Hydroquinone National Drug Code 42851-038-80 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42851-038-80 | ZO Skin Health Pigment Control Creme Hydroquinone | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 42851-038-80 | ZO Skin Health Pigment Control Creme Hydroquinone | 80 mL in 1 BOTTLE, PLASTIC | LOTION | 80 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ZO Skin Health Pigment Control Creme Hydroquinone
- Hydroquinone
- WATER
- ASCORBIC ACID
- ASCORBYL PALMITATE
- CAPRYLYL GLYCOL
- CETYL ALCOHOL
- CHLORPHENESIN
- DIOSCOREA VILLOSA TUBER
- EDETATE DISODIUM ANHYDROUS
- GLYCERIN
- GLYCOLIC ACID
- PHENOXYETHANOL
- QUILLAJA SAPONARIA BARK
- SMILAX ARISTOLOCHIIFOLIA ROOT
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- SODIUM METABISULFITE
- SODIUM SULFITE
- STEARYL ALCOHOL
- .ALPHA.-TOCOPHEROL ACETATE
- YUCCA SCHIDIGERA ROOT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42851-038 | 42851-038-80 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| dd82a6af-aa21-98ba-e053-2995a90a5540 | d9285ffa-6114-4798-9b16-169d2bb67355 | 2022-04-25 | Warnings | dd82a6af-aa21-98ba-e053-2995a90a5540 d9285ffa-6114-4798-9b16-169d2bb67355 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.