Label: ACNE DEEP PORE CLEANSING WASH- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Helps keep skin clear of new acne, acne blemishes, acne pimples and blackheads
  • 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.
    • avoid contact with eyes. If contact occurs, flush thoroughly with water.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Moisten face and apply by massaging face gently, avoiding the delicate eye area.
    • Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. Pat dry.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times 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

    Purified Water, Disodium Laureth Sulfosuccinate, Cocamidopropyl Hydroxysultaine (Coconut Derived), Cocamidopropylamine Oxide, PEG-150 Distearate, Polysorbate 20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin (Vegetable Derived), Lavandula Angustifolia (Lavender) Oil, Aniba Rosodora (Rosewood) Wood Oil, Salix Alba (Willow) Bark Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Decyl Glucoside (Plant Derived), Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.

    1
    Certified Organic Ingredients
  • SPL UNCLASSIFIED SECTION

    Distributed by DERMA E®
    Simi Valley, CA 93065, USA

  • PRINCIPAL DISPLAY PANEL - 175 mL Bottle Label

    ANTI-ACNE

    100% VEGAN • GMO-FREE
    ECO-ETHICAL
    CRUELTY-FREE

    DERMA•E

    Acne Deep Pore
    Cleansing Wash

    Active Salicylic Acid
    with Tea Tree Oil + Chamomile

    6 FL OZ / 175 mL

    PRINCIPAL DISPLAY PANEL - 175 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ACNE DEEP PORE CLEANSING WASH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-3700
    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)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-3700-1175 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00601/01/2015
    Labeler - derma e (148940450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(54108-3700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(54108-3700)
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