EXUVIANCE DAILY ACNE PEEL (SALICYLIC ACID) LIQUID [NEOSTRATA COMPANY INC.]

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EXUVIANCE DAILY ACNE PEEL (SALICYLIC ACID) LIQUID [NEOSTRATA COMPANY INC.]
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NDC 58414-0017-1
Set ID e9f7da8a-c595-4500-89f1-ec8a2a72ef59
Category HUMAN OTC DRUG LABEL
Packager NeoStrata Company Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Uses

    • Clears acne blemishes, acne pimples, blackheads and whiteheads
    • Allows skin to heal
    • Helps prevent new acne blemishes from forming
  • Warnings

    For external use only

    Do not use during pregnancy/lactation

    Keep out of eyes

    Rinse with water to remove

    When using this product

    • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor

    Stop use and ask a doctor if

    • Too much skin irritation or sensitivity develops or increases

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away

    Flammable- keep away from fire or flame

  • Directions

    • Clean the skin thoroughly before applying medication
    • Using a cotton pad, cover the affected area with a thin layer 1 to 3 times daily, avoiding eye area
    • Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor
    • If bothersome peeling or dryness occurs, reduce applications to once a day or every other day
    • For new users, apply product sparingly with pad to 1 or 2 small affected areas for approximately 3 days. If no discomfort occurs, follow directions above
    • Wash hands after applying
  • Other information

    • Store at 15°C-30°C (59°F-86°F)
  • Inactive ingredients

    Alcohol Denat., Diisopropyl Adipate, Cyclopentasiloxane, Propylene Glycol, Triethyl Citrate, Cyclohexasiloxane, Citric Acid, Tartaric Acid, BHT.

  • Questions or comments?

    Call toll free 1-800-225-9411 (9am-5pm ET)

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    exuviance®

    FOCUS

    oily
    acne prone

    DAILY ACNE
    PEEL

    Clear blemishes,
    black/white-heads
    Formulated to
    smooth texture,
    reduce oiliness

    2% Salicylic Acid
    acne solution
    Citric Acid and
    Tartaric Acid
    CitraFill

    100 mL/3.4 fl oz

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EXUVIANCE DAILY ACNE PEEL 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-0017
    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
    ALCOHOL (UNII: 3K9958V90M)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TARTARIC ACID (UNII: W4888I119H)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58414-0017-11 in 1 CARTON06/15/201809/30/2021
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:58414-0017-21 in 1 CARTON12/01/2019
    2100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/15/2018
    Labeler - NeoStrata Company Inc. (605754829)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Laboratories, Inc.001535103MANUFACTURE(58414-0017)
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