J1003005 JASON DANDRUFF RELIEF (SULFUR, SALICYLIC ACID) SHAMPOO [THE HAIN CELESTIAL GROUP, INC.]

J1003005 JASON DANDRUFF RELIEF (SULFUR, SALICYLIC ACID) SHAMPOO [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0030-8
Set ID 625e8306-78c4-3317-e053-2991aa0afe81
Category HUMAN OTC DRUG LABEL
Packager The Hain Celestial Group, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Sulfur 2.4%

    Salicylic Acid 2.2%



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  • PURPOSE


    Sulfur Controls Dandruff

    Salicylic Acid Controls Seborrheic Dermatitis



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  • INDICATIONS & USAGE

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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    J1003005 JASON DANDRUFF RELIEF 
    sulfur, salicylic acid shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0030
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 2.4 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61995-0030-8 355 g in 1 BOTTLE; Type 0: Not a Combination Product 11/27/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 11/27/2017
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Registrant - The Hain Celestial Group, Inc. (858894996)
    Establishment
    Name Address ID/FEI Business Operations
    The Hain Celestial Group, Inc 014334364 manufacture(61995-0030)
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