NDC | 42851-032-32, 42851-033-32, 42851-185-79 |
Set ID | 26c4c405-c698-4de4-a98f-33a29490aa0a |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- DOSAGE AND ADMINISTRATION
-
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
- STORAGE
- ACTIVE INGREDIENT
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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.
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- DOSAGE AND ADMINISTRATION
-
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
- STORAGE
- ACTIVE INGREDIENT
-
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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH MULTI-THERAPY HYDROQUINONE SYSTEM
hydroquinone kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42851-185 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-185-79 1 in 1 CARTON 03/01/2018 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 creamProduct Information Item Code (Source) NDC:42851-032 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 g 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) SUNFLOWER OIL (UNII: 3W1JG795YI) Maltodextrin (UNII: 7CVR7L4A2D) Phenoxyethanol (UNII: HIE492ZZ3T) QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW) SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Metabisulfite (UNII: 4VON5FNS3C) STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38) Stearyl Alcohol (UNII: 2KR89I4H1Y) Tocopherol (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-032-32 32 g 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 03/01/2018 Part 2 of 4 MELAMIX SKIN LIGHTENER AND BLENDING
hydroquinone creamProduct Information Item Code (Source) NDC:42851-033 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 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetyl Alcohol (UNII: 936JST6JCN) Glycerin (UNII: PDC6A3C0OX) Ethylhexyl Palmitate (UNII: 2865993309) Sodium Lauryl Sulfate (UNII: 368GB5141J) Stearyl Alcohol (UNII: 2KR89I4H1Y) SUNFLOWER OIL (UNII: 3W1JG795YI) Maltodextrin (UNII: 7CVR7L4A2D) Phenyl Trimethicone (UNII: DR0K5NOJ4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Phenoxyethanol (UNII: HIE492ZZ3T) Ascorbic Acid (UNII: PQ6CK8PD0R) Aminopropyl Dihydrogen Phosphate (UNII: D5J0Q2CM4V) Sodium Metabisulfite (UNII: 4VON5FNS3C) Glycolic Acid (UNII: 0WT12SX38S) BROCCOLI SPROUT (UNII: 128UH9LOAE) Ascorbyl Palmitate (UNII: QN83US2B0N) Chlorphenesin (UNII: I670DAL4SZ) Caprylyl Glycol (UNII: 00YIU5438U) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) STACHYS OFFICINALIS FLOWERING TOP (UNII: D7A759WU38) Sodium Sulfite (UNII: VTK01UQK3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-033-32 32 g 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 03/01/2018 Part 3 of 4 ZO SKIN HEALTH EXFOLIATION ACCELERATOR
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR Glycolic Acid (UNII: 0WT12SX38S) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR Glycerin (UNII: PDC6A3C0OX) INGR PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) INGR Propylene Glycol (UNII: 6DC9Q167V3) INGR AMMONIA (UNII: 5138Q19F1X) INGR Cetyl Alcohol (UNII: 936JST6JCN) INGR Squalane (UNII: GW89575KF9) INGR Steapyrium Chloride (UNII: C9842BS3SX) INGR Allantoin (UNII: 344S277G0Z) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR Dimethicone (UNII: 92RU3N3Y1O) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SAFFLOWER OIL (UNII: 65UEH262IS) INGR CHAMOMILE (UNII: FGL3685T2X) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR Ethylhexylglycerin (UNII: 147D247K3P) INGR Phenoxyethanol (UNII: HIE492ZZ3T) 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 Cosmetic 03/01/2018 Part 4 of 4 ZO SKIN HEALTH DAILY POWER DEFENSE
lotions, oils, powders, and creams lotionProduct 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 POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR Retinol (UNII: G2SH0XKK91) INGR 1,2-Hexanediol (UNII: TR046Y3K1G) INGR HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) INGR ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) INGR ORANGE OIL (UNII: AKN3KSD11B) INGR MANDARIN OIL (UNII: NJO720F72R) INGR LEMON OIL (UNII: I9GRO824LL) INGR PEPPERMINT OIL (UNII: AV092KU4JH) INGR MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) INGR TANGERINE (UNII: KH3E3096OO) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Farnesol (UNII: EB41QIU6JL) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) 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 (UNII: 9E8X80D2L0) 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, PUMP; Type 0: Not a Combination Product 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 Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(42851-185) Establishment Name Address ID/FEI Business Operations PhytogenX, Inc. 624386772 MANUFACTURE(42851-185) Establishment Name Address ID/FEI Business Operations PakLab 790530976 MANUFACTURE(42851-185)