Label: DEEP PORE ACNE SCRUB- salicylic acid paste

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

Drug Label Information

Updated November 8, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • 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, 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

    • Apply a small amount to wet skin.
    • Cover the entire affected area with a thin layer, gently massage in circular motion. Rinse thoroughly with warm water and 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, Cetyl Alcohol (Plant Derived), Prunus Armeniaca (Apricot) Seed Powder, Stearic Acid (Vegetable Derived), Glyceryl Stearate Citrate (Vegetable Derived), Hydroxypropyl Starch Phosphate (Sugar Starch), Caprylic/Capric Triglyceride (Vegetable Derived), Glycerin (Vegetable Derived), Decyl Glucoside (Plant Derived), Xanthan Gum, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Aniba Rosodora (Rosewood) Wood Oil, Salix Alba (Willow) Bark Extract, Allantoin, Organic Aloe Barbadensis (Aloe Vera) Extract1, Organic Simmondsia Chinensis (Jojoba) Seed Oil1, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Polysorbate 60, Polysorbate 20, Glyceryl Stearate SE, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.


    1
    Certified Organic Ingredients
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    ANTI-ACNE

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

    DERMA•E

    Deep Pore
    Acne Scrub

    Active Salicylic Acid
    with Tea Tree Oil + Aloe Vera

    4 OZ / 113 g

    PRINCIPAL DISPLAY PANEL - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    DEEP PORE ACNE SCRUB 
    salicylic acid paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-3750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-3750-1113 g in 1 TUBE; 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)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(54108-3750)