![ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/c29cbc80-cb97-42d0-b796-ee487b0e85c5/zo-skin-01.jpg)
| NDC | 42851-036-30, 42851-036-33, 42851-036-80 |
| Set ID | c29cbc80-cb97-42d0-b796-ee487b0e85c5 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | ZO Skin Health, Inc. |
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| Product Class | |
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| Application Number |
- SPL UNCLASSIFIED SECTION
- 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.
- STORAGE
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
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, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Water, 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 PLUS BLENDING CREME HYDROQUINONE
hydroquinone emulsionProduct Information Product Type HUMAN PRESCRIPTION DRUG 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 Chloride (UNII: 451W47IQ8X) Sodium Hydroxide (UNII: 55X04QC32I) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Metabisulfite (UNII: 4VON5FNS3C) Sodium Sulfate (UNII: 0YPR65R21J) Sodium Sulfite (UNII: VTK01UQK3G) Stearyl Alcohol (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Water (UNII: 059QF0KO0R) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-036-80 1 in 1 CARTON 05/01/2018 1 80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:42851-036-33 1 in 1 CARTON 05/01/2018 04/01/2019 2 33 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:42851-036-30 1 in 1 CARTON 05/01/2018 3 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 05/01/2018 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 ANALYSIS(42851-036) , LABEL(42851-036) , MANUFACTURE(42851-036) , PACK(42851-036) , RELABEL(42851-036) , REPACK(42851-036) Establishment Name Address ID/FEI Business Operations PureTek Corporation 080095015 LABEL(42851-036) , MANUFACTURE(42851-036) , PACK(42851-036) , RELABEL(42851-036) , REPACK(42851-036)
