X OUT DAILY BODY SCRUB (SALICYLIC ACID) CREAM [THE PROACTIV COMPANY LLC]

X OUT DAILY BODY SCRUB (SALICYLIC ACID) CREAM [THE PROACTIV COMPANY LLC]
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NDC 11410-059-40, 11410-059-79
Set ID cde33fe0-f793-4a7e-949b-9d982cab5172
Category HUMAN OTC DRUG LABEL
Packager THE PROACTIV COMPANY LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Use

    For the management of acne

  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness are 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.
    • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply a small amount to dampened skin.
    • cover the entire affected area with a thin layer and rinse thoroughly 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 once a day or every other day.
  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Paraffin, Distearyl Phthalic Acid Amide, Cetyl Alcohol, Stearyl Alcohol, Sodium Chloride, Sodium Methyl Cocoyl Taurate, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Menthol, Butylene Glycol, Hexylene Glycol, Caprylyl Glycol, PEG-120 Methyl Glucose Dioleate, Isopropyl Alcohol, Sodium Sulfite, Sodium Benzoate, Disodium EDTA, Coconut Acid, Ascorbic Acid, Ethylhexylglycerin, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Potassium Sorbate, Fragrance

    Questions or comments?
    Within US 1-800-524-7952

  • PRINCIPAL DISPLAY PANEL - 120 mL Label

    X OUT

    DAILY
    BODY SCRUB
     
    From the Makers of Proactiv®               

    salicylic acid acne treatment
    4 FL. OZ. · 120 mL

    Distributed by: The Proactiv Company LLC
    100 N Sepulveda Blvd., El Segundo, CA 90245
    XOut.com ● Made in the USA of Foreign and Domestic Components
    X Out is a trademark of The Proactiv Company Sàrl.

    DT.LAB038_X Out Daily Body Scrub 4oz_010516 FDA.jpg
  • INGREDIENTS AND APPEARANCE
    X OUT DAILY BODY SCRUB 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Menthol (UNII: L7T10EIP3A)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Sodium Sulfite (UNII: VTK01UQK3G)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Coconut Acid (UNII: 40U37V505D)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-059-79240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    2NDC:11410-059-40120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/28/2017
    3NDC:11410-059-101 in 1 CARTON02/01/2020
    310 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D09/28/2017
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-059)

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