Label: ANTI-DANDRUFF- salicylic acid shampoo

  • 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 September 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2.0%

  • Purpose

    Controls Dandruff

  • Uses

    • Controls recurrence of flaking, scaling and itching associated with dandruff
  • Warnings

    • For External use only

    • Keep out of reach of children

    • Avoid contact with the eyes

    • If contact occurs, rinse eyes thoroughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.
  • Directions

    • Gently massage into damp hair and scalp
    • Leave on for 2-3 minutes
    • Rinse thoroughly
    • For best results, use at least twice a week or as directed by a doctor
  • Other Information

    • Store between 40° to 100° F (4° to 38° C)
    • Protect from sunlight
    • Protect from freezing
  • Inactive Ingredients

    Aqua, Aloe Barbadensis (Leaf Juice/jus de feuilles), Sodium Laurylglucosides Hydroxypropylsulfonate, Coco-Betaine, Sodium Methyl Cocoyl Taurate, Decyl Glucoside, Glycerin, Panthenol, Malachite (Extract/extrait), Smithsonite (Extract/extrait), Rhodochrosite (Extract/extrait), Hematite (Extract/extrait), Dimethicone, Undecylenic Acid, Mica, Titanium Dioxide, Melaleuca Alternifolia (Tea Tree Leaf Oil/l'huile de feuilles), Guar Hydroxypropyltrimonium Chloride, Origanum Vulgare (Oregano Leaf Extract/extrait de feuilles), Citric Acid, Maris Limus, Sodium Benzoate, Potassium Sorbate, Ethylhexylglycerin, Natural Fragrance/Fragrance Naturelle (Parfum).

  • Questions or Comments

    Call 1-800-428-1668

    Monday-Friday 8 AM MST-5 PM MST

  • SPL UNCLASSIFIED SECTION

    Distributed by
    mineral fusion natural brands™
    600 West Bayaud Ave.
    Denver, CO 80223

  • PRINCIPAL DISPLAY PANEL - 250 mL Tube Label

    MINERAL FUSION®
    minerals on a mission®

    anti-dandruff
    shampoo
    CONTROLS THE SYMPTOMS
    OF DANDRUFF

    Controls flakes
    Removes build up
    Promotes scalp health

    GLUTEN FREE :: CRUELTY FREE :: SULFATE FREE

    250 mL / 8.5 fl oz e

    Principal Display Panel - 250 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    ANTI-DANDRUFF 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-1734
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM LAUROYL HYDROXYPROPYL SULFONATE (UNII: IQ398K5X8M)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CUPRIC CARBONATE (UNII: 9AOA5F11GJ)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    MANGANESE CARBONATE (UNII: 9ZV57512ZM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    OREGANO (UNII: 0E5AT8T16U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-1734-1250 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H08/01/2013
    Labeler - Mineral Fusion Natural Brands (831770032)
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