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

  • NDC Code(s): 71819-006-04, 71819-006-10, 71819-006-12, 71819-006-64, view more
    71819-006-99
  • Packager: D3 Development, 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 March 26, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    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 or shampoo.
    • 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/expiration date are printed on bottom of this bottle.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Potassium Cocoate, Potassium Oleate, Potassium Olivate, Sodium Acrylates / Beheneth-25 Methacrylate Crosspolymers, Pumice, Glycerin, Acrylates Copolymer, Citric Acid

  • 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

    Sulfur & Salicylic Acid SOAP

    For Dandruff, Sebhorreic Dermatitis & Psoriasis

    MEDICATED NATURAL CASTILE SOAP

    4 FL OZ (118 ml)

    Sulf - SA Liq Soap 71819-006

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY SULFUR AND SALICYLIC ACID 
    salicylic acid, sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PUMICE (UNII: NT5NN5KL16)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM OLIVATE (UNII: 3H8EO46QKE)  
    POTASSIUM OLEATE (UNII: 74WHF607EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-006-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    2NDC:71819-006-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    3NDC:71819-006-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    4NDC:71819-006-641893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    5NDC:71819-006-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/27/2020
    Labeler - D3 Development, Inc. (043195877)
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