Label: DERMAHARMONY 10% SULFUR- sulfur soap

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

Drug Label Information

Updated December 20, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sulfur 10%

  • PURPOSE

    Purpose

    Acne medication soap

  • INDICATIONS & USAGE

    Uses

    • For the treatment of acne.
    • Clears acne blemishes, blackheads, and whiteheads.
  • WARNINGS

    Warnings

    For external use only

    Do not use on

    • broken skin.
    • large areas of the skin.

    When using this product

    • apply only to areas with acne.
    • 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.

    Stop use and ask a doctor ifskin irritation occurs or gets worse.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • using warm water, wash affected area for 1-2 minutes, avoiding contact with the eyes.
    • rinse thoroughly and pat dry with a clean towel.
    • because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2-3 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.
  • STORAGE AND HANDLING

    Other informationStore at room temperature in a dry place.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, sodium chloride, coconut (Cocos nucifera) fruit extract, palm (Elaeis guineensis) fruit extract, pentasodium penetate

    *May contain this ingredient

  • QUESTIONS

    Questions?

    1-800-827-3730www.dermaharmony.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: D3 Development, Inc., Portland, ME 04101

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    10% Sulfur SOAP

    For Acne Pimples, Blackheads & Whiteheads

    NET WT 4 OZ (113 G)

    71819-014 SulfurSoap Final

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY 10% SULFUR 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ELAEIS GUINEENSIS FRUIT (UNII: 80T6U6714J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    COCONUT (UNII: 3RT3536DHY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-014-04113 g in 1 POUCH; Type 0: Not a Combination Product07/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/20/2021
    Labeler - D3 Development, Inc. (043195877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vanguard Soap, LLC.831404954manufacture(71819-014)
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