ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT (SALICYLIC ACID) GEL [ZO SKIN HEALTH, INC.]

ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT (SALICYLIC ACID) GEL [ZO SKIN HEALTH, INC.]
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NDC 42851-072-01
Set ID e9df51c5-d681-496b-b1ef-3c4e7b84be29
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid, 2.0%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Other Information

    • Store at controlled room temperature:
      15-30°C (59-89°F), away from direct sunlight
    • You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618
  • Inactive ingredients

    Water (Aqua), SD Alcohol 40-B (Alcohol Denat.), PEG-8, Dimethicone, Arbutin, PVM/MA Decadiene Crosspolymer, Aminopropyl Kojyl Phosphate, Pentylene Glycol, Glycerin, Sodium Hydroxide, Aminopropyl Dihydrogen Phosphate, Acetyl Glucosamine, Dimethicone/PEG-10/15 Crosspolymer, Trisiloxane, Helianthus Annuus Seed Oil, Prunus Amygdalus Dulcis Oleosomes, Mel Extract, Trimethylsiloxysilicate/Dimethiconol Crosspolymer, Alcohol, Brassica Oleracea Italica Extract, Glutathione, Sodium Sulfite, Polysorbate 80, Lecithin, Soy Isoflavones.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc.
    Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

    ZO®MEDICAL

    BY ZEIN OBAGI, MD

    NDC 42851-072-01

    AKNEBRIGHT™
    Acne Spot and
    Pigmentation Treatment

    15 mL / 0.5 Fl. Oz.

    Principal Display Panel - 15 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ARBUTIN (UNII: C5INA23HXF)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BARLEY MALT SYRUP (UNII: 22P8DKP670)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-072-011 in 1 CARTON
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/03/2014
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAKLAB790530976MANUFACTURE(42851-072)

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