NDC | 42851-035-81 |
Set ID | d7bfa71b-ddce-437e-abf9-2837af82c54d |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- DOSAGE AND ADMINISTRATION
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WARNINGS
Keep out of reach of children. 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.
- STORAGE
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Ascorbic Acid, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer, Ethoxydiglycol, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Plukenetia Volubilis Seed Oil, Retinyl Palmitate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Squalane, Tocopherol, Tocopheryl Acetate, Zanthoxylum Bungeanum Fruit Extract.
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 81 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C
hydroquinone emulsionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42851-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 0.04 mg in 1 mL Inactive Ingredients Ingredient Name Strength Ascorbic Acid (UNII: PQ6CK8PD0R) Ascorbyl Palmitate (UNII: QN83US2B0N) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Caprylyl Trisiloxane (UNII: Q95M2P1KJL) Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X) Dimethicone (UNII: 92RU3N3Y1O) Dimethicone Crosspolymer (450000 MPA.S AT 12% IN Cyclopentasiloxane) (UNII: UF7620L1W6) Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B) Sunflower Oil (UNII: 3W1JG795YI) Oleyl Alcohol (UNII: 172F2WN8DV) Plukenetia Volubilis Seed Oil (UNII: 8ED72Z8J1Z) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Rosemary (UNII: IJ67X351P9) Squalane (UNII: GW89575KF9) Tocopherol (UNII: R0ZB2556P8) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Zanthoxylum Bungeanum Fruit (UNII: 3CIP16A418) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-035-81 1 in 1 CARTON 05/01/2018 1 81 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 05/01/2018 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 ANALYSIS(42851-035) , LABEL(42851-035) , MANUFACTURE(42851-035) , PACK(42851-035) , RELABEL(42851-035) , REPACK(42851-035) Establishment Name Address ID/FEI Business Operations PureTek Corporation 080095015 LABEL(42851-035) , MANUFACTURE(42851-035) , PACK(42851-035) , RELABEL(42851-035) , REPACK(42851-035)