ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM

ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM- hydroquinone and titanium dioxide
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

After cleansing, 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 (Aqua), Ascorbic Acid, Glycolic Acid, Cetyl Alcohol, Glycerin, Sodium Lauryl Sulfate, Stearyl Alcohol, Tocopheryl Acetate, BHT, Disodium EDTA, Methylparaben, Propylparaben, Saponins, Sodium Metabisulfite.

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

Combine 1g tretinoin with 1 pump Melamix™ at night to affected areas or as directed by a physician, directly following Melamin™ for a gradual bleaching of hyperpigmented skin conditions. (See enclosed package insert for full prescribing information.)

Mild Start 1-2×/week, increasing as tolerated.
Moderate Use every other day, increasing as tolerated.
Aggressive Use every AM and PM as tolerated. Always use sunscreen protection.

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 (Aqua), Glycolic Acid, Glycerin, Cetyl Alcohol, Ethylhexyl Palmitate, Ascorbic Acid, Sodium Lauryl Sulfate, Phenyl Trimethicone, Saponins, Tocopheryl Acetate, Methylparaben, Propylparaben, Sodium Metabisulfite, BHT, Disodium EDTA.

OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50

Drug Facts

Active ingredient

Titanium Dioxide 8%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Other information

  • Store product in a cool place away from direct heat and sunlight.
  • You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618

Directions

  • For full protection, apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • For children under 6 months of age: ask a doctor.
  • Sun Protection Measures. Spending time in the sun increases your risk off skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    Limit time in the sun, especially from 10 a.m.- 2 p.m.
    Wear long-sleeved shirts, pants, hats and sunglasses.
  • Apply to all skin exposed to the sun.

Inactive ingredients

Water (Aqua), Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja Extract, Silica, C13-14 Isoparaffin, Laureth-7.

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

PRINCIPAL DISPLAY PANEL — Kit Carton

ZO® MULTI-THERAPY HYDROQUINONE SYSTEM

NDC 42851-131-98

ZO ® MEDICAL
BY ZEIN OBAGI, MD

RX
ONLY

Principal Display Panel -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
ZO MEDICAL GLYCOGENT Exfoliation Accelerator Concentration CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM
hydroquinone and titanium dioxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42851-131
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-131-98 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 TUBE 60 g
Part 4 1 BOTTLE, PLASTIC 30 mL
Part 5 1 BOTTLE, PUMP 30 mL
Part 1 of 5
MELAMIN SKIN BLEACHING AND CORRECTING
hydroquinone cream
Product Information
Item Code (Source) NDC:42851-030
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
Ascorbic Acid
Butylated Hydroxytoluene
Cetyl Alcohol
Edetate Disodium
Glycerin
Glycolic Acid
Methylparaben
Propylparaben
Water
Sodium Lauryl Sulfate
Sodium Metabisulfite
Stearyl Alcohol
.Alpha.-Tocopherol Acetate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-030-32 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 01/01/2012
Part 2 of 5
MELAMIX SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
Item Code (Source) NDC:42851-031
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
Ascorbic Acid
Butylated Hydroxytoluene
Cetyl Alcohol
Edetate Disodium
Ethylhexyl Palmitate
Glycerin
Glycolic Acid
Methylparaben
Phenyl Trimethicone
Propylparaben
Water
Sodium Lauryl Sulfate
Sodium Metabisulfite
.Alpha.-Tocopherol Acetate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-031-32 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 01/01/2012
Part 3 of 5
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50
titanium dioxide lotion
Product Information
Item Code (Source) NDC:42851-052
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.08 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
STEARIC ACID
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)
CYCLOMETHICONE 5
ALUMINUM HYDROXIDE
PHENYL TRIMETHICONE
EDETATE DISODIUM
PENTYLENE GLYCOL
DIMETHICONE
GLYCERIN
LAURYL LACTATE
ISODECYL NEOPENTANOATE
DIISOPROPYL SEBACATE
POLYACRYLAMIDE (1500 MW)
SODIUM DIHYDROXYCETYL PHOSPHATE
PHYTOSPHINGOSINE
HYDROGENATED PALM GLYCERIDES
MELAMINE
ERYTHRITOL
HOMARINE HYDROCHLORIDE
NEPHELIUM LAPPACEUM FRUIT RIND
SILICON DIOXIDE
C13-14 ISOPARAFFIN
LAURETH-7
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
CAPRYLYL GLYCOL
CHLORPHENESIN
ETHYLHEXYLGLYCERIN
SODIUM BENZOATE
POTASSIUM SORBATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42851-052-60 60 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 06/01/2013
Part 4 of 5
ZO MEDICAL GLYCOGENT EXFOLIATION ACCELERATOR CONCENTRATION
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCOLIC ACID
MEDIUM-CHAIN TRIGLYCERIDES
LACTIC ACID, UNSPECIFIED FORM
SODIUM HYDROXIDE
GLYCERIN
PROPYLENE GLYCOL
CETYL ALCOHOL
SQUALANE
PROPYLENE GLYCOL MONOSTEARATE
STEAPYRIUM CHLORIDE
ETHYLHEXYLGLYCERIN
ALOE VERA LEAF
SAFFLOWER OIL
ALLANTOIN
GREEN TEA LEAF
EDETATE DISODIUM
PHENOXYETHANOL
SODIUM CARBONATE
SODIUM CHLORIDE
DIMETHICONE
BUTYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
TOCOPHEROL
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 01/01/2012
Part 5 of 5
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
CETEARYL ISONONANOATE
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PENTYLENE GLYCOL
RETINOL
EGG PHOSPHOLIPIDS
POLYSORBATE 20
GLYCERIN
STEARETH-20
CETOSTEARYL ALCOHOL
JOJOBA BUTTER
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
CURDLAN
LACTOSE, UNSPECIFIED FORM
ORANGE OIL
MANDARIN OIL
LEMON OIL
PEPPERMINT OIL
MIMOSA TENUIFLORA BARK
ARABIDOPSIS THALIANA
C14-22 ALCOHOLS
CETEARYL GLUCOSIDE
C12-20 ALKYL GLUCOSIDE
POWDERED CELLULOSE
BUTYLENE GLYCOL
PALMITOYL HEXAPEPTIDE-12
PALMITOYL TETRAPEPTIDE-7
SODIUM HYDROXIDE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
HYPROMELLOSES
HEXYLENE GLYCOL
EDETATE DISODIUM
CAPRYLYL GLYCOL
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
LIMONENE, (+/-)-
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 01/11/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/01/2014
Labeler — ZO Skin Health, Inc. (826468527)
Establishment
Name Address ID/FEI Operations
Sanitor Corporation 797472792 MANUFACTURE (42851-131)
Establishment
Name Address ID/FEI Operations
PhytogenX, Inc. 624386772 MANUFACTURE (42851-131)
Establishment
Name Address ID/FEI Operations
PAKLAB 790530976 MANUFACTURE (42851-131)

Revised: 04/2016 ZO Skin Health, Inc.

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