ZO SKIN HEALTH OIL CONTROL PADS ACNE TREATMENT (SALICYLIC ACID) PATCH [ZO SKIN HEALTH, INC.]

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ZO SKIN HEALTH OIL CONTROL PADS ACNE TREATMENT (SALICYLIC ACID) PATCH [ZO SKIN HEALTH, INC.]
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NDC 42851-085-30, 42851-085-60
Set ID 84283a64-8f31-4e98-ad04-948dbe94887d
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid 2.0%

  • Purpose

    Acne treatment

  • Uses

    • for the management of acne.
    • penetrates pores to control acne blemishes.
  • Warnings

    Flammable. Keep away from heat and open flame.

    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.

    Stop use and ask a doctor if

    • skin irritation occurs or gets worse.

    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

    • Read the directions and warnings before use.
    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.

  • SPL UNCLASSIFIED SECTION

    Dist. by ZO Skin Health, Inc. Irvine, CA 92618

    Made in USA with US & imported materials

    zoskinhealth.com | 925000

  • PRINCIPAL DISPLAY PANEL - 60 Pad Jar Carton

    ZO ® SKIN HEALTH

    BY ZEIN OBAGI MD

    NDC 42851-085-60

    OIL CONTROL PADS

    ACNE TREATMENT

    2% Salicylic Acid

    60 Pads

    US Oil Control Pads - Unit Carton

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH OIL CONTROL PADS ACNE TREATMENT 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-085
    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
    MANDELIC ACID (UNII: NH496X0UJX)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-085-601 in 1 CARTON11/01/2017
    160 in 1 JAR
    10.8 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:42851-085-301 in 1 CARTON07/11/2018
    230 in 1 JAR
    20.8 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/01/2017
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    LIFETECH RESOURCES LLC622559110manufacture(42851-085)
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