Label: EPIONCE PURIFYING SPOT GEL- sulfur gel

  • NDC Code(s): 42673-007-00, 42673-007-01
  • Packager: Episciences, Inc.
  • 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 June 3, 2022

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  • Active ingredients

    Sulfur 3.3%

  • Purpose

    Acne Treatment

  • Use

    • 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, use only one topical acne medication at a time
    • apply only to areas with acne
    • rinse right away with water if it gets in eyes.

    Do not use on

    • broken skin
    • large areas of skin

    Stop use and ask a doctor

    • if skin irritation occurs or gets worse

    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 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 gradulally 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

    Azelaic Acid, Butylene Glycol, Caprylyl Glycol, Coconut Oil, Ethylhexylglycerin, Glycerin, Helianthus Annuus Flowering Top, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%), Levomenthol, Medium-Chain Triglycerides, Orange Oil, Paprika, Phenoxyethanol, Pyrithione Zinc, Quercetin, Resorcinol Monoacetate, Rice Bran, Rosemary, Safflower Oil, Spearmint Oil, Sulfur, Tocopherol, Water

  • Questions?

    Call toll free 1-866-374-6623

  • PRINCIPAL DISPLAY PANEL

    Epionce Purifying Spot Gel Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    EPIONCE PURIFYING SPOT GEL 
    sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.033 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    RICE BRAN (UNII: R60QEP13IC)  
    ROSEMARY (UNII: IJ67X351P9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PAPRIKA (UNII: X72Z47861V)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PYRITHIONE ZINC (UNII: R953O2RHZ5)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    QUERCETIN (UNII: 9IKM0I5T1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    RESORCINOL MONOACETATE (UNII: YL6O37RD1S)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42673-007-011 in 1 BOX10/02/201805/31/2024
    1NDC:42673-007-0010 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/02/201805/31/2024
    Labeler - Episciences, Inc. (144733040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Episciences, Inc.144733040manufacture(42673-007)
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