Zo® Skin Health Pigment Control + Blending Crème 4% Hydroquinone

Zo® Skin Health Pigment Control + Blending Crème 4% Hydroquinone
SPL v4
SPL
SPL Set ID c29cbc80-cb97-42d0-b796-ee487b0e85c5
Route
TOPICAL
Published
Effective Date 2019-04-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroquinone (0.04 g)
Inactive Ingredients
Ascorbic Acid Ascorbyl Palmitate Caprylyl Glycol Cetyl Alcohol Chlorphenesin Dioscorea Villosa Tuber Edetate Disodium Anhydrous Ethylhexyl Palmitate Glycerin Glycolic Acid Palmitic Acid Phenoxyethanol Phenyl Trimethicone Quillaja Saponaria Bark Smilax Aristolochiifolia Root Sodium Chloride Sodium Hydroxide Sodium Lauryl Sulfate Sodium Metabisulfite Sodium Sulfate Sodium Sulfite Stearyl Alcohol .alpha.-tocopherol Acetate Water Yucca Schidigera Root

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-05-01 Until 2019-04-01

Description

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

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

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

Section 42229-5

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

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

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, Water, Yucca Schidigera Root Extract.

Principal Display Panel 80 Ml Bottle Carton

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

PIGMENT CONTROL +

BLENDING CRÈME

4% Hydroquinone

RX ONLY

NDC 42851-036-80

80 mL / 2.7 Fl. Oz.


Structured Label Content

Section 42229-5 (42229-5)

Blending crème containing 4% hydroquinone, the optimal concentration for melanin inhibition to correct skin pigmentation disorders.

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)

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, Water, 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 +

BLENDING CRÈME

4% Hydroquinone

RX ONLY

NDC 42851-036-80

80 mL / 2.7 Fl. Oz.


Advanced Ingredient Data


Raw Label Data

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