Label: DERMAHARMONY SULFUR AND SALICYLIC ACID- salicylic acid, sulfur soap

  • Category: HUMAN OTC DRUG LABEL

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 2, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Salicylic acid 2%

    Sulfur 5%

  • PURPOSE

    Purpose

    Dandruff / sebhorreic dermatitis / psoriasis soap

  • INDICATIONS & USAGE

    Uses

    ​Helps prevent and control recurrence of itching, flaking and irritation associated with dandruff, sebhorreic dermatitis, and psoriasis

  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if you have a condition that covers a large area of the body.

  • WHEN USING

    When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Use on affected areas in place of your regular soap.
    • For best results use at least twice a week or as directed by a doctor.
    • Work up a lather using warm water and massage into affected areas.
    • Rinse.
  • STORAGE AND HANDLING

    Other information

    • Store at 59° to 77°F (15° to 25°C)
    • Lot number and expiration date are printed on back panel
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, soyethyl morpholinium ethosulfate (soy derived), sodium chloride, pentasodium pentetate

    *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 the USA

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    5% Sulfur & 2% Salicylic Acid SOAP

    For Dandruff, Sebhorreic Dermatitis & Psoriasis

    NET WT 4 OZ (113 G)

    SA-Sulfur Soap V5 Final

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY SULFUR AND SALICYLIC ACID 
    salicylic acid, sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-004-04113 g in 1 CELLO PACK; Type 0: Not a Combination Product07/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/02/2019
    Labeler - D3 Development, Inc. (043195877)
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