NDC | 42851-037-30, 42851-037-80 |
Set ID | 83e34a75-d20c-43ab-be31-f8fcafec46d0 |
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. 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, 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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE
hydroquinone emulsionProduct Information Product Type HUMAN PRESCRIPTION DRUG 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 NDC:42851-037-80 1 in 1 CARTON 04/15/2018 1 80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:42851-037-30 1 in 1 CARTON 07/01/2018 2 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 04/15/2018 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 ANALYSIS(42851-037) , LABEL(42851-037) , MANUFACTURE(42851-037) , PACK(42851-037) , RELABEL(42851-037) , REPACK(42851-037) Establishment Name Address ID/FEI Business Operations PureTek Corporation 080095015 LABEL(42851-037) , MANUFACTURE(42851-037) , PACK(42851-037) , RELABEL(42851-037) , REPACK(42851-037)