Label: DERMA E ACNE CLARIFYING MASK- sulfur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Colloidal Sulfur 10.0%

  • 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.
    • Apply only to areas with acne.

    Do not use on

    • broken skin
    • large areas of the skin.

    Keep out of reach of children.

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

  • Directions

    • New User: Apply product sparingly to one or two affected areas.Test for the first 3 days. If you do not experience any discomfort, Follow instructions below.
    • Apply to clean face, avoiding the eye and lip area.
    • Cover the entire affected area with a thin layer.
    • Leave on for 10-15 minutes. Rinse thoroughly with warm water or remove with a damp cloth.
    • Pat skin dry. Apply 2-3 times a week.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Bentonite, Kaolin, Glycerin (Vegetable Derived), Diatomaceous Earth, Allantoin, Niacinamide, Zinc PCA, Glycosaminoglycans, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Bakuchiol, Zinc Oxide, Camellia Sinensis Leaf Extract, Sodium Alginate, Daucus Carota Sativa (Carrot) Seed Oil, Bois de Rose (Rosewood) Oil, Bromelain, Salix Alba (Willow) Bark Extract, Papain, Rosmarinus Officinalis (Rosemary) Leaf Extract, Resveratrol, Humulus Lupulus (Hops) Extract, Yeast Extract, Iron Oxide (CI 77492), Camphor, Lavendula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citric Acid, Phenoxyethanol.

  • Questions or comments?

    Call toll free 1-800-933-9344
    or visit dermae.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Box

    ANTI-ACNE

    100% VEGAN • SOY-FREE
    CRUELTY-FREE

    ECO-ETHICAL

    DERMA • E

    Acne Sulfur
    Clarifying Mask

    10% Colloidal Sulfur
    Bentonite Clay
    Willow Bark Extract

    targets pores, acne
    and controls oil

    • DERMATOLOGIST
    RECOMMENDED •

    2 OZ / 57 g

    PRINCIPAL DISPLAY PANEL - 57 g Tube Box
  • INGREDIENTS AND APPEARANCE
    DERMA E ACNE CLARIFYING MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-3710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    ALLANTOIN (UNII: 344S277G0Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    BROMELAINS (UNII: U182GP2CF3)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    PAPAIN (UNII: A236A06Y32)  
    ROSEMARY (UNII: IJ67X351P9)  
    RESVERATROL (UNII: Q369O8926L)  
    HOPS (UNII: 01G73H6H83)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-3710-51 in 1 BOX12/14/2022
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/14/2022
    Labeler - derma e (148940450)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(54108-3710)
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