Label: DERMAHARMONY 10% SULFUR- sulfur soap

  • 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 July 20, 2021

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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 if skin 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 information Store 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?

    1-800-827-3730 www.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 finalpart333D07/20/2021
    Labeler - D3 Development, Inc. (043195877)
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