Label: CLEAR AND COVER ACNE TREATMENT CONCEALER CLEAR AND COVER ACNE TREATMENT CONCEALER 13 FUDGE- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 12, 2019

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 2%

    Purpose

    Acne Treatment

  • Use

    • for the treatment of acne
    • clears acne blemishes
    • helps prevent new acne blemishes
  • 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 three times daily
    • becaused excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three tiems 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
  • Inactive ingredients

    Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Dimethicone, Trisiloxane, Kaolin, Polyisobutene, PEG/PPG-18/18 Dimethicone, Boron Nitride, Cyclodextrin, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Trimethylsiloxysilicate, Phenoxyethanol, Bisabolol, Caprylyl Glycol, Glycerin, Triethoxycaprylylsilane, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol, Tocopheryl Acetate, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate.
    May Contain (+/-): Zinc Oxide (CI 77947), Iron Oxides (CI 77491/CI 77492/CI 77499).

  • Package Labeling:

    Outer Package2Inner Package2fudge

  • INGREDIENTS AND APPEARANCE
    CLEAR AND COVER ACNE TREATMENT CONCEALER CLEAR AND COVER ACNE TREATMENT CONCEALER  13 FUDGE
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31720-965
    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)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    TALC (UNII: 7SEV7J4R1U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31720-965-181 in 1 BOX06/01/2020
    13.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2020
    Labeler - S+ (572406531)
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