Label: ITK BODY BLEMISH TREATMENT MIST- salicylic acid spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne.
  • Warnings

    • For external use only.
    • Flammable: Do not use near heat, flame, or while smoking.

    • When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor.

    • Stop use and ask a doctor if rash occurs.
    • Avoid contact with eyes. If contact occurs, flush thoroughly with water.

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

    • Clean skin thoroughly before applying.
    • Use morning or night. Close eyes and mist onto clean, dry skin.
    • Wait 20 – 30 seconds to dry before dressing or applying other products.
  • Inactive Ingredients

    Water (Aqua/Eau), Alcohol Denat., Butylene Glycol, PPG-26- Buteth-26, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Glycerin, Mentha Piperita (Peppermint) Oil, Sodium Hydroxide, Glycyrrhiza Glabra (Licorice) Root Extract, Menthol, tert-Butyl Alcohol, Denatonium Benzoate, Limonene, Linalool.

  • Questions, Comments

    YOU MAY REPORT AN ADVERSE REACTION TO: ITK C/O REPORT REACTION LLC, PO BOX 22, PLAINSBORO, NJ 08536-0222.

  • SPL UNCLASSIFIED SECTION

    Dist. by Maesa LLC, New York, NY 10281

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    itk

    SCAN ME

    BLEMISH
    TREATMENT MIST

    treats acne
    + controls daily oil

    3.3 FL. OZ. / 100 mL

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ITK BODY BLEMISH TREATMENT MIST 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71899-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71899-070-011 in 1 CARTON08/01/2022
    1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00608/01/2022
    Labeler - MAESA, LLC. (144282311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetica Labs255080491MANUFACTURE(71899-070)
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