ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM (SALICYLIC ACID) KIT [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM (SALICYLIC ACID) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-078-07, 42851-172-07
Set ID a82129fc-0b0d-4ade-96cd-94917caac930
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

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-172
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-172-071 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 40 mL
    Part 21 JAR 16.2 g
    Part 31 BOTTLE, GLASS 75 mL
    Part 1 of 3
    OFFECTS EXFOLIATING CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMANNITOL (UNII: 3OWL53L36A)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRDISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    INGRCAPRYLIC ALCOHOL (UNII: NV1779205D)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRAMMONIUM LACTATE (UNII: 67M901L9NQ)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRNIACIN (UNII: 2679MF687A)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRSODIUM GLYCOLATE (UNII: B75E535IMI)  
    INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGRNIACINAMIDE (UNII: 25X51I8RD4)  
    INGRBIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRCHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC
    Part 2 of 3
    OFFECTS EXFOLIATING POLISH 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRMAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGROLETH-20 (UNII: YTH167I2AG)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRTRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRD&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116.2 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing 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 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2011
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110MANUFACTURE(42851-172)

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