Label: DERMAHARMONY SEBORRHEIC DERMATITIS- pyrithione zinc cream

  • NDC Code(s): 71819-002-03, 71819-002-06, 71819-002-08
  • 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 October 26, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 0.25%

  • PURPOSE

    Purpose

    Seborrheic dermatitis cream

  • INDICATIONS & USAGE

    Uses

    • Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis
    • Helps eliminate recurrence of seborrheic dermatitis
  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if condition 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 of the product 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to affected area one to four times daily

  • STORAGE AND HANDLING

    Other information

    • Store at 59° to 77°F (15° to 25°C)
    • Lot number and expiration date can be found on lid.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose

  • QUESTIONS

    Questions?

    1-800-827-3730

    www.dermaharmony.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc.

    Portland, ME 04101

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    Seborrheic Dermatitis CREAM

    Contains 0.25% Pyrithione Zinc

    3 FL OZ (89 ml)

    Seb Derm Cream FINAL

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY SEBORRHEIC DERMATITIS 
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%) (UNII: 6OX6A5C7B6)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    WATER (UNII: 059QF0KO0R)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-002-0389 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2019
    2NDC:71819-002-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
    3NDC:71819-002-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/26/2019
    Labeler - D3 Development, Inc. (043195877)
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