Label: DERMA E ACNE BLEMISH CONTROL TREATMENT SERUM- salicylic acid liquid

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

Drug Label Information

Updated April 30, 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
  • 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

    • SHAKE WELL
    • 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, Glycerin, Hydroxypropyl Starch Phosphate (Sugar Starch), Salix Alba (Willow) Bark Extract, Epilobium Angustifolium (Canadian Willowherb) Extract, Aniba Rosodora (Rosewood) Wood Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), Organic Camellia Sinensis (Green Tea) Leaf Extract1, Aloe Barbadensis (Aloe Vera) Leaf Juice1, Caffeine, Hamamelis Virginiana (Witch Hazel) Extract, Lavandula Angustifolia (Lavender) Oil, Carrageenan (Seaweed Derived), Citric Acid, Potassium Hydroxide, Polysorbate 20, Xanthan Gum, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.

    1
    Certified Organic Ingredients
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 60 mL Jar Box

    ANTI-ACNE

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

    DERMA • E

    Acne Blemish
    Control
    Treatment
    Serum

    Active Salicylic Acid
    Tea Tree Oil
    Aloe Vera

    reduces acne,
    blackheads and breakouts

    • DERMATOLOGIST •
    RECOMMENDED

    2 FL OZ / 60 mL

    Principal Display Panel - 60 mL Jar Box
  • INGREDIENTS AND APPEARANCE
    DERMA E ACNE BLEMISH CONTROL TREATMENT SERUM 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-3851
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%) (UNII: GSS77345H7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-3851-11 in 1 BOX02/22/2022
    160 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00602/22/2022
    Labeler - derma e (148940450)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc049121643MANUFACTURE(54108-3851)
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