Label: FACIAL FORTRESS- pyrithione zinc shampoo

  • NDC Code(s): 71566-200-08
  • Packager: Pediatric Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione Zinc 0.95%

  • Purpose

    Seborrheic Dermatitis and Dandruff

  • Uses

    Helps eliminate scalp and skin scaling, redness, flaking, itching, and irritation associated with dandruff and seborrheic dermatitis.

  • Warnings

    For external use only.

    Ask a doctor before use if you have• seborrheic dermatitis covering 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 of this product as directed.

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

  • Directions •

    For best results use at least twice a week or as directed by a doctor.

    • Wet hair thoroughly, massage on to scalp and skin, rinse.
  • Inactive ingredients

    Water (Aqua), Glycerin, Sodium Lauroyl Methyl Isethionate, Sodium Laurylglucosides Hydroxypropylsulfonate, Cocamidopropyl Hydroxysultaine, Acrylates Copolymer, Pyrus Malus (Apple) Fruit Extract, Phenoxyethanol, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Dipotassium Glycyrrhizate, Panthenol, Ethylhexylglycerin, Citric Acid.

  • Principal Display Panel – 237 mL Bottle Label

    Dr. Eddie's
    FACIAL
    FORTRESS™
    3 in 1
    Face, Hair &
    Beard Wash

    PYRITHIONE ZINC • ANTI-DANDRUFF • DYE FREE • FRAGRANCE FREE
    ANTI-SEBORRHEIC DERMATITIS-DERMATOLOGIST TESTED

    8 fl. oz. (237 ml.)

    Principal Display Panel – 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FACIAL FORTRESS 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71566-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.0095 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
    APPLE (UNII: B423VGH5S9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71566-200-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/13/2024
    Labeler - Pediatric Solutions, LLC (080736513)
    Establishment
    NameAddressID/FEIBusiness Operations
    kdc/one Chatsworth, Inc.118542196manufacture(71566-200)
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