Label: DEEP ACNE- sulfur gel

  • NDC Code(s): 68479-240-00, 68479-240-02
  • Packager: Dermalogica, LLC.
  • 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 November 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sulfur...5.00%

  • Purpose

    Acne Treatment

  • Use

    • For the treatment of acne
  • Warnings

    For external use only

    Do not use

    • On broken skin or large areas of the skin.

    When using this product

    • Apply only to areas with acne.
    • Skin irritation and dryness are 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.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Clean the skin thoroughly before applying this product.
    • Apply to areas of congestion, and allow 3-5 minutes to fully activate.
  • Inactive ingredients

    Water/Aqua/Eau, Niacinamide, Propanediol, Glycerin, Acacia Senegal Gum, Polyacrylate Crosspolymer-6, Hydroxyacetophenone, Lactic Acid, Pelargonium Graveolens Flower Oil, Lavandula Hybrida Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Salvia Sclarea (Clary) Oil, Aloe Barbadensis Leaf Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Punica Granatum Pericarp Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Myristyl Myristate, Beta-Glucan, Biosaccharide Gum-1, Glyceryl Stearate, Maltodextrin, Caprylyl Glycol, Polylysine, Cetearyl Alcohol, 1,2-Hexanediol, Sodium Acrylates Crosspolymer-2, Ceteareth-12, Titanium Dioxide, Tetrasodium Glutamate Diacetate, Potassium Cetyl Phosphate, Sodium Hydroxide, Dimethyl Isosorbide, Thymol, Terpineol, Algin, Camphor, O-Cymen-5-Ol, Sodium Benzoate, Limonene, Linalool, Citronellol, Geraniol.

  • Questions or comments

    Call toll free 1-800-831-5150 in the US

  • PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

    deep acne
    liquid patch

    with 5% sulfur +
    camphor

    invisible
    acne
    treatment

    dermalogica

    Active Clearing

    0.5 US FL OZ / 15 mL e

    PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    DEEP ACNE 
    sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Niacinamide (UNII: 25X51I8RD4)  
    Propanediol (UNII: 5965N8W85T)  
    Glycerin (UNII: PDC6A3C0OX)  
    ACACIA (UNII: 5C5403N26O)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    Myristyl Myristate (UNII: 4042ZC00DY)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Sodium Acrylates Crosspolymer-2 (UNII: D3HPR4WW6F)  
    Hydroxyacetophenone (UNII: G1L3HT4CMH)  
    Ceteareth-12 (UNII: 7V4MR24V5P)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    o-Cymen-5-ol (UNII: H41B6Q1I9L)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    Terpineol (UNII: R53Q4ZWC99)  
    Thymol (UNII: 3J50XA376E)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Biosaccharide Gum-1 (UNII: BB4PU4V09H)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Geraniol (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-240-021 in 1 CARTON12/01/2022
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-240-002 mL in 1 POUCH; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2022
    Labeler - Dermalogica, LLC. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    McKenna090631412MANUFACTURE(68479-240)
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