Label: PAULAS CHOICE CLEAR ANTI REDNESS EXFOLIATING SOLUTION- salicylic acid liquid

  • NDC Code(s): 76144-620-01, 76144-620-02
  • Packager: Paula's Choice, LLC.
  • 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 June 6, 2022

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  • ACTIVE INGREDIENT

    Salicylic Acid

  • PURPOSE

    • Treats acne
    • Helps clear acne blemishes, blackheads, and whiteheads
    • Helps prevent new acne blemishes
  • DOSAGE & ADMINISTRATION

    After cleansing with Paula's Choice Clear Pore Normalizing Cleanser, soak a large cotton ball with Regular Strength Anti-Redness Exfoliating Solution and gently stroke over the face, paying special attention to acne and blackhead prone areas. Do not rinse. Avoid contact with eyes, eyelids, and mucous membranes. If contact occurs, rinse with water. If excessive dryness or peeling occurs, reduce application to once per day or once every other day.

    If contact occurs, rinse with water. If excessive dryness or peeling occurs, reduce application to once per day or once every other day.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • on broken skin
    • on large areas of the body
  • ASK DOCTOR

    Stop use and ask a doctor if too much skin irritation or skin sensitivity develops or increases.

  • WHEN USING

    When using this product

    · Do not use in or near the eyes

    · Using other topical acne products at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help and contact a Poison Control Center immediately.

  • OTHER SAFETY INFORMATION

    • Store at 20-25ºC (68-77ºF).
    • You may report serious adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057
  • INACTIVE INGREDIENT

    Water, Dipropylene Glycol, Pentylene Glycol, Polysorbate 20, Butylene Glycol, Glycerin, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Allantoin. Panthenol, PEG/PPG-17/6 Copolymer, Methyl Gluceth-20, Glycereth-26, Bis-PEG-18 Methyl Ether Dimethyl Silane, Sodium Hydroxide, Sodium Metabisulfite, Tetrasodium EDTA

  • PRINCIPAL DISPLAY PANEL

    Full Size Component Label

  • Trial Size Artwork

    Trial Size Artwork

  • INGREDIENTS AND APPEARANCE
    PAULAS CHOICE CLEAR ANTI REDNESS EXFOLIATING SOLUTION 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-620
    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)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
    BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76144-620-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2009
    2NDC:76144-620-0230 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package01/14/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/17/2009
    Labeler - Paula's Choice, LLC. (029583981)