Label: ANTIDANDRUFF- pyrithione zinc 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 May 19, 2016

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  • Active Ingredient:

    Pyrithione Zinc 1%

  • Uses:

    Fights and helps prevents recurrence of flacking and itching associated with dandruff

  • Warnings:

    For external use only.

  • When using this product:

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop using this product and consult a doctor:

    if conditions worsen or does not improve after regular use of this product as directed.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Center immediately.

  • Directions:

    For best results use at least twice a week or as directed by a dcoctor.

    Apply shampoo, massaging it thoroughly into the scalp. Rinse and repeat.

    Professional product.

  • Inactive ingredients:

    AQUA (WATER), SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, LAURAMIDOPROPYL BETAINE, PROPYLENE GLYCOL, SODIUM PCA, PEG-7 GLYCERYL COCOATE, PEG-200 HYDROGENATED GLYCERYL PALMATE, PARFUM (FRAGRANCE), BENZYL ALCHOL, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, TETRASODIUM EDTA, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, URTICA DIOICA (NETTLE) LEAF EXTRACT, MENTHA PIPERITA (MINT) EXTRACT, PEG/PPG-14/4 DIMETHICONE, PIROCTONE OLAMINE, CITRIC ACID, PANTHENOL, MENTHOL

  • PRINCIPAL DISPLAY PANEL

    artworkGREEN

    CARE

    ESSENCE

    ANTI-DANDRUFF

    SHAMPOO

    SAGE NETTLE MINT

    PYRITHIONE ZINC

  • INGREDIENTS AND APPEARANCE
    ANTIDANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70549-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PEG-200 HYDROGENATED GLYCERYL PALMATE (UNII: W161T051Y1)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PEG/PPG-14/4 DIMETHICONE (UNII: 646XNV22YX)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MENTHOL (UNII: L7T10EIP3A)  
    SAGE (UNII: 065C5D077J)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70549-123-111000 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
    2NDC:70549-123-22250 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/01/2016
    Labeler - BBCOS S.R.L. (434126395)
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