Label: ALOE COAL 02 CONDITIONER- 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

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

View All Sections
  • 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:

    After shampooing, apply conditioner by gently massaging into hair and scalp. Rinse thoroughly until water runs clear.

    For best results, let conditioner 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, Behentrimonium Methosulfate, Biotin, Cetearyl Alcohol, Cetearyl Olivate, Citrus Grandis (Grapefruit) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Guar Hydroxypropyltrimonium Chloride, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Rice Protein, Mangifera Indica (Mango) Butter, di-Panthenol, Phenoxyethanol, Ricinus Communis (Castor) Oil, Rosa Canina (Rose Hips) Oil, Silk Amino Acids, Silybum Marianum (Milk Thistle) Extract, Simmondsia Chinensis (Jojoba) Oil, Sorbitan Olivate, Zemea (Corn) Propanediol

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ALOE COAL 02 CONDITIONER 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73324-090
    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)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    BIOTIN (UNII: 6SO6U10H04)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MANGO (UNII: I629I3NR86)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    MILK THISTLE (UNII: U946SH95EE)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73324-090-08237 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)
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!