ZO SKIN HEALTH PIGMENT CONTROL PROGRAM PLUS HYDROQUINONE- hydroquinone kit

ZO Skin Health Pigment Control Program Plus Hydroquinone by

Drug Labeling and Warnings

ZO Skin Health Pigment Control Program Plus Hydroquinone by is a Prescription medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PIGMENT CONTROL CRÈME
(Hydroquinone USP, 4%)

RX ONLY
FOR EXTERNAL USE ONLY:
NOT FOR OPHTHALMIC USE

DESCRIPTION

Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

The structural formula is:

Each gram of Pigment Control Creme (Hydroquinone USP, 4%) contains Hydroquinone USP 40mg/gm in a base of purified water, 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.

CLINICAL PHARMACOLOGY

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

INDICATIONS AND USAGE

Pigment Control Creme is indicated in the gradual bleaching of hyperpigmentation, skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

CONTRAINDICATIONS

Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

WARNINGS

Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

PRECAUTIONS

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Drug Interactions

Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

Pregnancy Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

Overdosage

There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

DRUG DOSAGE AND ADMINISTRATION

A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

HOW SUPPLIED

Pigment Control Creme (Hydroquinone USP, 4%) is available as follows:

2.7 Fl. Oz. (80 mL) Bottle / NDC: 42851-037-80

1.0 fl oz/30 ml Bottle / NDC: 42851-037-30

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F)

SPL UNCLASSIFIED SECTION

PIGMENT CONTROL + BLENDING CREME
(Hydroquinone USP, 4%)

RX ONLY
FOR EXTERNAL USE ONLY:
NOT FOR OPHTHALMIC USE

DESCRIPTION

Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

The structural formula is:

Each gram of Pigment Control + Blending Creme contains Hydroquinone USP 40mg/gm in a base of 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, Purified Water, 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.

CLINICAL PHARMACOLOGY

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

INDICATIONS AND USAGE

For the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

CONTRAINDICATIONS

Prior history of sensitivity or allergic reaction to hydroquinone or to any other ingredient in this product. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

WARNINGS

Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

PRECAUTIONS

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Drug Interactions

Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

Pregnancy Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

Overdosage

There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

DRUG DOSAGE AND ADMINISTRATION

A thin application of Pigment Control + Blending Creme should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under 12 years of age except under the advice and supervision of a physician.

HOW SUPPLIED

Pigment Control + Blending Creme (Hydroquinone USP, 4%) is available as follows:

2.7 Fl. Oz. (80 mL) Bottle / NDC: 42851-036-80

1.0 Fl. Oz (30ml) Bottle / NDC: 42851-036-30

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F)

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

PIGMENT CONTROL PROGRAM
+ HYDROQUINONE

NDC: 42851-184-60

GENTLE CLEANSER 60 mL / 2 Fl. Oz.

EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.

COMPLEXION RENEWAL PADS 30 Pads

PIGMENT CONTROL CRÈME 30 mL / 1.0 Fl. Oz.

DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

PIGMENT CONTROL + BLENDING CREME 30 mL / 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH PIGMENT CONTROL PROGRAM PLUS HYDROQUINONE 
hydroquinone kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42851-184

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-184-60	1 in 1 CARTON	11/28/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	60 mL
Part 2	1 JAR	16.2 g
Part 3	1 JAR	30
Part 4	1 BOTTLE, PLASTIC	30 mL
Part 5	1 BOTTLE	30 mL
Part 6	1 BOTTLE, PLASTIC	30 mL

Part 1 of 6

ZO SKIN HEALTH GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/28/2018

Part 2 of 6

ZO SKIN HEALTH EXFOLIATING POLISH 
lotions, oils, powders, and creams suspension

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	SODIUM BICARBONATE (UNII: 8MDF5V39QO)
INGR	MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	OLETH-20 (UNII: YTH167I2AG)
INGR	TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	WATER (UNII: 059QF0KO0R)
INGR	.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
INGR	TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	D&C GREEN NO. 6 (UNII: 4QP5U84YF7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		16.2 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/28/2018

Part 3 of 6

ZO SKIN HEALTH COMPLEXION RENEWAL PADS 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	UREA (UNII: 8W8T17847W)
INGR	GLYCOLIC ACID (UNII: 0WT12SX38S)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
INGR	ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/28/2018

Part 4 of 6

ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE 
hydroquinone emulsion

Product Information
Item Code (Source)	NDC: 42851-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM SULFITE (UNII: VTK01UQK3G)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/28/2018

Part 5 of 6

ZO SKIN HEALTH DAILY POWER DEFENSE 
lotions, oils, powders, and creams emulsion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	C14-22 ALCOHOLS (UNII: B1K89384RJ)
INGR	CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INGR	C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	MANDARIN OIL (UNII: NJO720F72R)
INGR	TANGERINE (UNII: KH3E3096OO)
INGR	LEMON OIL (UNII: I9GRO824LL)
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	FARNESOL (UNII: EB41QIU6JL)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
INGR	PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)
INGR	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/28/2018

Part 6 of 6

ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE 
hydroquinone emulsion

Product Information
Item Code (Source)	NDC: 42851-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM SULFITE (UNII: VTK01UQK3G)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/28/2018

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	manufacture(42851-184)

Establishment
Name	Address	ID/FEI	Business Operations
LIFETECH RESOURCES LLC		081239587	manufacture(42851-184)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	manufacture(42851-184)