ZO Skin Health Multi-Therapy Hydroquinone System: Package Insert and Label Information

ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM- hydroquinone
ZO Skin Health, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

MELAMIN™ Skin Bleaching & Correcting Crème

Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

DOSAGE AND ADMINISTRATION

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

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 afterwards.

STORAGE

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

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Aqua/Water/Eau, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Brassica Oleracea Italica (Broccoli) Extract, C10-16 Alcohols, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Lauryl Sulfate, Sodium Metabisulfite, Stachys Officinalis Flower/ Leaf/Stem Extract, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

MELAMIX™ Skin Lightener & Blending Crème

Indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation.

DOSAGE AND ADMINISTRATION

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

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 afterwards.

STORAGE

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

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Water, Cetyl Alcohol, Glycerin, Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Maltodextrin, Phenyl Trimethicone, Tocopheryl Acetate, Phenoxyethanol, Ascorbic Acid, Aminopropyl Dihydrogen Phosphate, Beta-Glucan, Sodium Metabisulfite, Glycolic Acid, Brassica Oleracea Italica (Broccoli) Sprout Powder, Ascorbyl Palmitate, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stachys Officinalis Flower/Leaf/ Stem Extract, Saponins, Sodium Sulfite.

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL — Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

MULTI-THERAPY HYDROQUINONE SYSTEM

NDC 42851-185-79

MELAMIN™ Net Wt. 32 g / 1.12 Oz.
EXFOLIATION ACCELERATOR 30 mL / 1 Fl. Oz.
MELAMIX™ Net Wt. 32 g / 1.12 Oz.
DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
ZO Skin Health Exfoliation Accelerator LOTIONS, OILS, POWDERS, AND CREAMS
ZO Skin Health Daily Power Defense LOTIONS, OILS, POWDERS, AND CREAMS
ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM
hydroquinone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42851-185
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-185-79 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 32 g
Part 2 1 BOTTLE, PLASTIC 32 g
Part 3 1 BOTTLE, PLASTIC 30 mL
Part 4 1 BOTTLE, PUMP 30 mL
Part 1 of 4
MELAMIN SKIN BLEACHING AND CORRECTING HYDROQUINONE
hydroquinone cream
Product Information
Item Code (Source) NDC:42851-032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 0.04 g in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Ascorbic Acid
Ascorbyl Palmitate
Caprylyl Glycol
Cetyl Alcohol
Chlorphenesin
DIOSCOREA VILLOSA TUBER
EDETATE DISODIUM ANHYDROUS
Glycerin
Glycolic Acid
SUNFLOWER OIL
Maltodextrin
Phenoxyethanol
QUILLAJA SAPONARIA BARK
SMILAX ARISTOLOCHIIFOLIA ROOT
Sodium Lauryl Sulfate
Sodium Metabisulfite
STACHYS OFFICINALIS FLOWERING TOP
Stearyl Alcohol
Tocopherol
.ALPHA.-TOCOPHEROL ACETATE
YUCCA SCHIDIGERA ROOT
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-032-32 32 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/01/2018
Part 2 of 4
MELAMIX SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
Item Code (Source) NDC:42851-033
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 0.04 g in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Cetyl Alcohol
Glycerin
Ethylhexyl Palmitate
Sodium Lauryl Sulfate
Stearyl Alcohol
SUNFLOWER OIL
Maltodextrin
Phenyl Trimethicone
.ALPHA.-TOCOPHEROL ACETATE
Phenoxyethanol
Ascorbic Acid
Aminopropyl Dihydrogen Phosphate
Sodium Metabisulfite
Glycolic Acid
BROCCOLI SPROUT
Ascorbyl Palmitate
Chlorphenesin
Caprylyl Glycol
EDETATE DISODIUM ANHYDROUS
STACHYS OFFICINALIS FLOWERING TOP
Sodium Sulfite
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-033-32 32 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/01/2018
Part 3 of 4
ZO SKIN HEALTH EXFOLIATION ACCELERATOR
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
Water
Glycolic Acid
MEDIUM-CHAIN TRIGLYCERIDES
LACTIC ACID, UNSPECIFIED FORM
Glycerin
PROPYLENE GLYCOL MONOSTEARATE
Propylene Glycol
AMMONIA
Cetyl Alcohol
Squalane
Steapyrium Chloride
Allantoin
EDETATE DISODIUM ANHYDROUS
Dimethicone
.ALPHA.-TOCOPHEROL ACETATE
SAFFLOWER OIL
CHAMOMILE
ALOE VERA LEAF
GREEN TEA LEAF
VITAMIN A PALMITATE
Ethylhexylglycerin
Phenoxyethanol
Packaging
# Item Code Package Description Multilevel Packaging
1 30 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/01/2018
Part 4 of 4
ZO SKIN HEALTH DAILY POWER DEFENSE
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
Water
Cetearyl Isononanoate
CYCLOMETHICONE 5
Glycerin
CYCLOMETHICONE 6
Pentylene Glycol
CETOSTEARYL ALCOHOL
Steareth-20
C14-22 Alcohols
Cetearyl Glucoside
C12-20 Alkyl Glucoside
CARBOXYPOLYMETHYLENE
LACTOSE, UNSPECIFIED FORM
POWDERED CELLULOSE
LECITHIN, SOYBEAN
Retinol
1,2-Hexanediol
HYPROMELLOSE, UNSPECIFIED
ARABIDOPSIS THALIANA
ORANGE OIL
MANDARIN OIL
LEMON OIL
PEPPERMINT OIL
MIMOSA TENUIFLORA BARK
TANGERINE
Polysorbate 20
Farnesol
LIMONENE, (+)-
EDETATE DISODIUM ANHYDROUS
Sodium Hydroxide
Palmitoyl Tripeptide-1
Palmitoyl Tetrapeptide-7
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
Caprylyl Glycol
Butylene Glycol
Hexylene Glycol
Ethylhexylglycerin
Phenoxyethanol
ULTRAMARINE BLUE
EXT. D&C VIOLET NO. 2
Packaging
# Item Code Package Description Multilevel Packaging
1 30 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/01/2018
Labeler — ZO Skin Health, Inc. (826468527)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE (42851-185)
Establishment
Name Address ID/FEI Operations
PhytogenX, Inc. 624386772 MANUFACTURE (42851-185)
Establishment
Name Address ID/FEI Operations
PakLab 790530976 MANUFACTURE (42851-185)

Revised: 02/2018 ZO Skin Health, Inc.

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