Label: ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE- hydroquinone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 42851-039-80 - Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 25, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
- Children under 12 years of age: do not use unless directed by a doctor.
- Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
- Other Information
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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, 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, Yucca Schidigera Root Extract
- Questions?
- 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 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-039 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 20 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) 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 (UNII: 9E8X80D2L0) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-039-80 1 in 1 CARTON 01/11/2019 09/23/2020 1 80 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 OTC monograph not final part358A 01/11/2019 Labeler - ZO Skin Health, Inc. (826468527)
