Label: CLARIFY BOTANICAL CLARIFYING WASH- salicylic acid gel

  • 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 September 14, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Salicylic Acid            2.00%

  • Purpose

    Acne Treatment

  • Uses

    For the treatment of acne.

  • 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, use only one topical medication at a time.

    • Keep out of reach of children
    • When using this product, rinse immediately with water if it gets in eyes.
    • If swallowed, consult a physician or poison control center.
  • Directions

    • Wet face. Apply to hands, add water and work into lather. Gently massage all over face being careful to avoid the eyes.
    • Rinse thoroughly and pat dry.
    • Use daily for best results.
  • Additional Information

    Store at room temperature.

  • Inactive ingredients

    Aqua (Deionized Water), Cocamidopropyl Betaine, Glycerin, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone, Polycrylate-1 Crosspolymer, Sodium C14-16 Olefin Sulfonate, Sulfur, FD&C Yellow #5.

  • Questions

    1 888 311 7444

  • SPL UNCLASSIFIED SECTION

    Distributed by: Schweiger Dermatology Group
    NY, NY 10019

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

    SKIN SOLUTIONS
    dr.Schweiger
    NEW YORK

    Clarify

    Botanical Clarifying Cleanser

    100 mL / 3.4 oz. e

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLARIFY   BOTANICAL CLARIFYING WASH
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70911-114
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Melaleuca Alternifolia Leaf (UNII: G43C57162K)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Sulfur (UNII: 70FD1KFU70)  
    FD&C Yellow NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70911-114-121 in 1 CARTON01/01/2017
    1NDC:70911-114-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/01/2017
    Labeler - SCHWEIGER DERMATOLOGY GROUP (007492566)
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