Label: ANTI DANDRUFF- salicylic acid rinse

  • 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 February 4, 2014

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  • WARNINGS


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

  • Drug Facts

    Salicylic Acid    2.0%

  • PURPOSE

    Controls symptoms of dandruff, seboric dermatitis and psoriasis

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    For relief of flaking, scaling and itching associated with dandruff. Helps prevent Seborrheic Dermatitis

  • DOSAGE & ADMINISTRATION

    For the best results use at least three times each week. Apply to clean, wet hair. Rinse throughly.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice (1), Aqua (Water), Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Stearic Acid,Cetyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Helianthus Annuus (Sunflower Seed Oi (1), Diheptyl Succinate, Stearyl Alcohol, Olea Europaea (Olive) Fruit Oil (1l, Simmondsia Chinensis (Jojoba) Seed Oil (1), Butyrospermum Parkii (Shea) Butter (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Eucalyptus Globulus Leaf Extract (1), Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract (1), Rosmarinus Officinalis (Rosemmary) Leaf Extract (1), Styrax Benzoin Resin Extract, Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) Leaf Oil , Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia  (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Wheat Protein, Menthol, Tocopheryl Acetate, Xanthan Gum, Alcohol, Benzyl Alcohol, Sodium Benzoate, Potassium Sorbate

    (1) Certified Organic Ingredients

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI DANDRUFF 
    salicylic acid rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 g  in 397 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    GERANIUM MACULATUM WHOLE (UNII: LFG25P7V8M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    POGOSTEMON CABLIN WHOLE (UNII: H6UKY25H2P)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1107-9397 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/17/2014
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture(61995-1107)
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