Label: J1003005 JASON DANDRUFF RELIEF- sulfur, salicylic acid shampoo

  • NDC Code(s): 61995-0030-8
  • Packager: The Hain Celestial Group, Inc.
  • 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 April 12, 2021

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  • ACTIVE INGREDIENT

    Sulfur 2.4%

    Salicylic Acid 2.2%



  • PURPOSE


    Sulfur Controls Dandruff

    Salicylic Acid Controls Seborrheic Dermatitis



  • INDICATIONS & USAGE

    • Controls recurrence of flaking, scaling and itching associated with dandruff
    • Helps prevent seborrheic dermatitis
  • WARNINGS

    For external use only . Avoid contact with eyes.Rinse eyes throughly with water in case contact occurs.Discontinue use and consult your physician if irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    For best results, use at least three times each week. Wet hair and lather,massage into scalp. Rinse and repeat if desired.

  • INACTIVE INGREDIENT

    Aqua (Water), Potassium Cocoyl Glutamate, Sodium Cocoyl Isothionate, Disodium Cocoamphodiacetate, Stearic Acid, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Olea Europaea (Olive) Fruit Oil (1), Chenopodium Quinoa Seed (1), Rosmarinus Officinalis (Rosemary) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Camphor, Menthol, Methyl Salicylate, Potassium Hydroxide, Sodium PCA, Xanthan Gum, Benzyl Alcohol, Capryloyl Glycine, Sodium Chloride, Undecylenoyl Glycine, Linalool.

    (1)

    Certified Organic Ingredients

  • PRINCIPAL DISPLAY PANEL

    bottle labels

  • INGREDIENTS AND APPEARANCE
    J1003005 JASON DANDRUFF RELIEF 
    sulfur, salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR2.4 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ALCOHOL (UNII: 3K9958V90M)  
    POTASSIUM COCOYL GLUTAMATE (UNII: IR5T90R7LZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0030-8355 g in 1 BOTTLE; Type 0: Not a Combination Product11/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/27/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc081512382manufacture(61995-0030)
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