Label: DERMA E ACNE MATTE MOISTURIZER- salicylic acid lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Salicylic Acid 0.53%

  • 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

    • 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.
  • Inactive ingredients

    Purified Water, Stearic Acid (Vegetable Derived), Caprylic/Capric Triglyceride (Vegetable Derived), Cetyl Alcohol (Plant Derived), Glyceryl Stearate Citrate (Vegetable Derived), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin (Vegetable Derived), Polysorbate 60, Salix Alba (Willow) Bark Extract, Aniba Rosodora (Rosewood) Wood Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil*, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Organic Aloe Barbadensis (Aloe Vera) Extract*, Allantoin, Panthenol (Provitamin B5), Xanthan Gum, Polysorbate 20, Glyceryl Stearate (Vegetable Derived), Cetearyl Glucoside (Plant Derived), Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Lavandula Angustifolia (Lavender) Oil.

    1
    Certified Organic Ingredients
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 56 g Tube Box

    ANTI-ACNE

    • SAME EFFECTIVE
    FORMULA •
    New
    Look!

    DERMA•E
    Acne Oil-Control
    Matte Moisturizer

    Active Salicylic Acid
    Tea Tree Oil & Aloe Vera
    rebalances sebum production

    • DERMATOLOGIST
    RECOMMENDED •

    2 OZ / 56 g

    PRINCIPAL DISPLAY PANEL - 56 g Tube Box
  • INGREDIENTS AND APPEARANCE
    DERMA E ACNE MATTE MOISTURIZER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-3900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-3900-11 in 1 BOX05/21/2021
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00605/21/2021
    Labeler - derma e (148940450)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc049121643MANUFACTURE(54108-3900)
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