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TE-Pads (ZO Skin Health)

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SWAB 75 mL in 1 BOTTLE, GLASS (42851-078-07) Label Information

Complete TE-Pads Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Salicylic Acid 2.0%


  • Purpose

    Acne Treatment


  • Uses

    Control acne breakouts, oiliness and soothe complexion.


  • Warnings

    For external use only.

    Talk to your doctor if you experience excessive burning, dryness, or irritation.

    Avoid the eyes, mouth, lips, and mucous membranes.

    Do not use on sunburned, windburned, dry, chapped, irritated, or wounded skin.

    Keep out of the reach of children.


  • Directions

    • Rinse and dry your face.
    • Use pads twice a day, AM and PM.

  • Sunburn Alert

    This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.


  • Other information

    You may report a serious adverse reaction to: 5 Technology Dr., Irvine, CA 92618


  • Inactive ingredients

    Water, Alcohol Denat., Propylene Glycol, Urea, Sodium Hydroxide, Fragrance, Glycolic Acid, Butylene Glycol, Denatonium Benzoate, t-Butyl Alcohol, Sodium Chloride, Sodium Carbonate, Spiraea Ulmaria Extract, Pterocarpus Santalinus Wood Extract, Plantago Major Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Vulgare Seed Extract, Crithmum Maritimum Extract, Camellia Sinensis Leaf Oil, Artemisia Vulgaris Extract, Phenoxyethanol.


  • SPL UNCLASSIFIED SECTION

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


  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI MD

    NDC 42851-172-07

    ZO® GSR SYSTEM

    For All Skin Types

    PRINCIPAL DISPLAY PANEL - Kit Carton

  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM 
    salicylic acid kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-172
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42851-172-07 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 40 mL
    Part 2 1 JAR 16.2 g
    Part 3 1 BOTTLE, GLASS 75 mL
    Part 1 of 3
    OFFECTS EXFOLIATING CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGR PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGR MANNITOL (UNII: 3OWL53L36A)  
    INGR SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGR SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGR DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    INGR CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGR EDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGR AMMONIUM LACTATE (UNII: 67M901L9NQ)  
    INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGR POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGR TEA TREE OIL (UNII: VIF565UC2G)  
    INGR NIACIN (UNII: 2679MF687A)  
    INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGR SODIUM GLYCOLATE (UNII: B75E535IMI)  
    INGR SALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGR NIACINAMIDE (UNII: 25X51I8RD4)  
    INGR BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGR HYPROMELLOSES (UNII: 3NXW29V3WO)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 40 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    COSMETIC
    Part 2 of 3
    OFFECTS EXFOLIATING POLISH 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGR MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR OLETH-20 (UNII: YTH167I2AG)  
    INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGR TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    INGR PEG-100 STEARATE (UNII: YD01N1999R)  
    INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGR TEA TREE OIL (UNII: VIF565UC2G)  
    INGR ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGR STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGR PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGR LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGR SOY STEROL (UNII: PL360EPO9J)  
    INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGR D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 16.2 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    COSMETIC
    Part 3 of 3
    OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM 
    salicylic acid solution
    Product Information
    Item Code (Source) NDC:42851-078
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42851-078-07 75 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 01/01/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2011
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    Name Address ID/FEI Business Operations
    Lifetech Resources 622559110 MANUFACTURE(42851-172)