OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM (SALICYLIC ACID) SOLUTION [ZO SKIN HEALTH, INC.]

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  • OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM (SALICYLIC ACID) SOLUTION [ZO SKIN HEALTH, INC.]

OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM (SALICYLIC ACID) SOLUTION [ZO SKIN HEALTH, INC.]
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NDC 42851-078-07, 42851-079-00
Set ID a7a21460-dbe5-4861-a727-442419e66883
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 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 two times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

    Water, SD Alcohol 40-B, Propylene Glycol, Urea, Fragrance, Glycolic Acid, t-Butyl Alcohol, Butylene Glycol, Spiraea Ulmaria Extract, Santalum Album (Sandalwood) Extract, Plantago Lanceolata Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Distichon (Barley) Extract, Crithmum Maritimum Extract, Camellia Sinensis Leaf Extract, Artemisia Vulgaris Extract, Phenoxyethanol, Denatonium Benzoate, Sodium Hydroxide.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI, MD

    OFFECTS®
    TE-PADS
    ACNE PORE TREATMENT
    SYSTEM

    NDC 42851-078-07

    60 Pads, 75 mL / 2.5 Fl. Oz.

    Principal Display Panel - 75 mL Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 20 Packet Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI, MD

    NDC 42851-079-00

    OFFECTS®
    TE-PADS
    ACNE PORE TREATMENT

    20 Single-Use Packettes (1mL / 0.03 Fl. Oz. each)

    Principal Display Panel - 20 Packet Carton
  • INGREDIENTS AND APPEARANCE
    OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-078
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    UREA (UNII: 8W8T17847W)  
    DALTEPARIN SODIUM (UNII: 12M44VTJ7B)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)  
    SANDALWOOD (UNII: 3641YW25N2)  
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    BARLEY (UNII: 5PWM7YLI7R)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-078-0775 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/01/2011
    OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-079
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    UREA (UNII: 8W8T17847W)  
    DALTEPARIN SODIUM (UNII: 12M44VTJ7B)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)  
    SANDALWOOD (UNII: 3641YW25N2)  
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    BARLEY (UNII: 5PWM7YLI7R)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-079-0020 in 1 CARTON
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D04/05/2015
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110MANUFACTURE(42851-078, 42851-079)
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