Label: ANTI DANDRUFF- salicylic acid shampoo

  • 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 January 28, 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. Wet hair, lather, massage onto scalp. Rinse and repeat if desired.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice (1),Aqua (Water), Sodium Coco-Sulfate, Cococ-Glucoside, Glyceryl Oleate, Chamomilla Recuitita (Matricaria) Flower Extract (1), Malaleuca Alternifolia (Tea Tree) Leaf Oil (1), Rosmarinus Officinalis (Rosemary) extract, Styrax Benzoin Resin Extract (1), Canarium Luzonicum Gum Nonvolatiles, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange Peel Oil, Citrus Limon (Lemon) Peel Oil,

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI DANDRUFF 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 g  in 414 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    CANARIUM LUZONICUM WHOLE (UNII: 5BH1ESR432)  
    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 ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    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)  
    INULIN (UNII: JOS53KRJ01)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1106-9414 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/29/2014
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture(61995-1106)
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