Zo® Skin Health Pigment Control Crème 4% Hydroquinone

Zo® Skin Health Pigment Control Crème 4% Hydroquinone
SPL v4
SPL
SPL Set ID 83e34a75-d20c-43ab-be31-f8fcafec46d0
Route
TOPICAL
Published
Effective Date 2019-04-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroquinone (40 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-04-15

Description

Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

Dosage and Administration

Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)


Medication Information

Dosage and Administration

Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

Description

Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

Section 42229-5

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

Storage

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

Warnings

Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions, including anaphylactic symptoms (e.g., hives, itching) and life-threatening or less-severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.

Active Ingredient

Hydroquinone 4%

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.

Principal Display Panel 80 Ml Bottle Carton

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

PIGMENT CONTROL

CRÈME

4% Hydroquinone

RX ONLY

NDC 42851-037-80

80 mL / 2.7 Fl. Oz.


Structured Label Content

Section 42229-5 (42229-5)

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

Storage (STORAGE)

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

Warnings (WARNINGS)

Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions, including anaphylactic symptoms (e.g., hives, itching) and life-threatening or less-severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.

Sunburn Alert (SUNBURN ALERT)

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.

Active Ingredient (ACTIVE INGREDIENT)

Hydroquinone 4%

Inactive Ingredients (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.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Apply 2 pumps (1g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

Principal Display Panel 80 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton)

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

PIGMENT CONTROL

CRÈME

4% Hydroquinone

RX ONLY

NDC 42851-037-80

80 mL / 2.7 Fl. Oz.


Advanced Ingredient Data


Raw Label Data

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