Label: ALOE COAL 01- pyrithione zinc liquid

  • 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 August 28, 2019

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  • Drug Facts

  • ACTIVE INGREDIENT:

    Pyrithione Zinc 1.00%

    PURPOSE

    Dandruff Treatment

  • USES:

    For relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent chance of recurrence.

  • WARNINGS

    For external use only.

    When using this product

    avoid contact with eyes. If this happens, rinse thoroughly with water.

    Stop and ask a doctor 

    if condition worsens or does not improve after using this product as directed.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    • Apply shampoo to wet hair by massaging into lather with pads of finger tips. Rinse thoroughly. 
    • For best results, let shampoo sit for 3-5 minutes before rinsing thoroughly. Use a least twice per week, or as directed by physician.
  • OTHER INGREDIENTS:

    Activated Charcoal Powder, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Avena Sativa (Oat) Protein, Biotin, Citrus Grandis (Grapefruit) Oil, Cocamidopropyl Betaine, Dimethicone, Equisetum Arvense (Horsetail) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Rice Protein, Olea Europaea (Olive) Oil, Lauryl Glucoside, di-Panthenol, Phenoxyethanol, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Sodium C14-16 Alpha Olefin Sulfonate, Sodium Cocoyl Isethionate, Sodium Lauryl Glucose Carboxylate

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    ALOE COAL 01 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73324-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    OAT (UNII: Z6J799EAJK)  
    BIOTIN (UNII: 6SO6U10H04)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73324-091-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/26/2019
    Labeler - T. SPRUILL, LLC (117054436)
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