Label: DERMAHARMONY FACE AND BODY- pyrithione zinc 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 March 13, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 2%

  • PURPOSE

    Purpose

    Dandruff / Seborrheic dermatitis

  • INDICATIONS & USAGE

    Uses

    Reduces the symptoms of dandruff and seborrheic dermatitis.

  • WARNINGS

    Warnings

    For external use only

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

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

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

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Use on affected areas in place of your regular soap / shampoo
    • For best results use at least twice a week or as directed by a doctor
    • Rub between hands to create a lather, or apply bar directly onto body / hair
    • Massage into the skin or scalp for 60-90 seconds, then rinse well
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, coco glucoside, water, soyethyl morpholinium ethosulfate, cetearyl alcohol & ceteareth-20, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, olive oil, tocopheryl acetate (vitamin E), sodium isostearoyl lactylate, iron oxides (yellow).

  • QUESTIONS

    Questions?

    1-800-827-3730

    www.dermaharmony.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc., Portland, ME 04101

    Made in USA of U.S. and imported ingredients.

    NDC Code: 71819-008-04

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    Face & Body

    with 2% Pyrithione Zinc

    FOR DANDRUFF & SEBORRHEIC DERMATITIS

    Reduces itching-irritation-redness-flaking-scaling

    NET WT 4 OZ (113G)

    Face-Body-Bar-V3

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY FACE AND BODY 
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-20 (UNII: L0Q8IK9E08)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    OATMEAL (UNII: 8PI54V663Y)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT ACID (UNII: 40U37V505D)  
    SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-008-04113 g in 1 CARTON; Type 0: Not a Combination Product03/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/15/2021
    Labeler - D3 Development, Inc. (043195877)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!