Label: DERMA E ACNE CLEANSING PADS- salicylic acid cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 28, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Salicylic Acid 1.9%

  • Purpose

    Anti-Acne

  • Uses

    • For the treatment of acne
    • Helps keep skin clear of new acne, acne blemishes, acne pimples and blackheads
  • Directions

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily.
    • 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.
  • 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.
  • Inactive ingredients:

    Purified Water, Alcohol Denat., Glycolic Acid, Polysorbate 20, Azelaic Acid, Lactic Acid, Mandelic Acid, Salix Alba (Willow) Bark Extract, Chamomilla Recutita (Matricaria) Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Panax Ginseng Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aniba Rosodora (Rosewood) Wood Oil, Lavandula Angustifolia (Lavender) Oil, Glycerin, Sodium Hydroxide, Sodium Phytate, Sodium Benzoate, Phenoxyethanol.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Jar Label

    DERMA•E

    Anti-Acne Deep Cleansing Pads

    Azelaic Acid, AHAs, BHAs & Anti-Blemish Complex
    for face + body

    • DERMATOLOGIST •
    RECOMMENDED

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

    50 PADS
    (1.7 FL OZ / 50 mL)

    PRINCIPAL DISPLAY PANEL - 50 mL Jar Label
  • INGREDIENTS AND APPEARANCE
    DERMA E ACNE CLEANSING PADS 
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-3725
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID190 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-3725-150 mL in 1 JAR; Type 0: Not a Combination Product05/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00605/23/2024
    Labeler - derma e (148940450)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc049121643MANUFACTURE(54108-3725)
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