ZO SKIN HEALTH OFFECTS CORRECT AND CONCEAL ACNE TREATMENT (LIGHT) (SALICYLIC ACID) STICK [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH OFFECTS CORRECT AND CONCEAL ACNE TREATMENT (LIGHT) (SALICYLIC ACID) STICK [ZO SKIN HEALTH, INC.]
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NDC 42851-076-02
Set ID 3e8375e6-9420-4226-b258-e3cda364da16
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:
      5 Technology Dr.
      Irvine, CA 92618
  • Inactive ingredients

    Euphorbia Cerifera (Candelilla) Cera, Beeswax, Polyethylene, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Phenyl Trimethicone, Polybutene, Octyldodecanol, Tridecyl Stearate, Neopentyl Glycol, Dicaprylate/Dicaprate, Cellulose, Disteardimonium Hectorite, Polyglyceryl-10 Heptahydroxystearate, Silica, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Propylene Carbonate, Water, Tridecyl Trimellitate, Triethyl Citrate, Glycerin, Zanthoxylum Bungeanum Fruit Extract, Jojoba Esters, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Ceramide NG, Trihydroxystearin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Alumina, Marrubium Vulgare Meristem Cell Culture, Leontopodium Alpinum Meristem Cell Culture, Honey, Phenoxyethanol, Lecithin, Sodium Benzoate, Titanium Dioxide, Iron Oxides.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 2.3 g Applicator Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI MD

    NDC 42851-076-02

    OFFECTS®
    CORRECT & CONCEAL
    ACNE TREATMENT

    LIGHT

    Net Wt. 2.3 g / 0.08 Oz.

    PRINCIPAL DISPLAY PANEL - 2.3 g Applicator Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH OFFECTS CORRECT AND CONCEAL ACNE TREATMENT (LIGHT) 
    salicylic acid stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    ROSEMARY (UNII: IJ67X351P9)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HONEY (UNII: Y9H1V576FH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-076-021 in 1 CARTON01/01/2016
    12.3 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2016
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hudson Cosmetics MFG Corp. DBA: Paramount Cosmetics, Inc.001321058MANUFACTURE(42851-076)

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