Label: SPAI-SONS ALKALINE DRY-DANDRUFF- 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 June 5, 2012

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  • ACTIVE INGREDIENT

    This formula includes Zinc Pyrithione used to eliminate the agent causing dry dandruff and scalp drying.
  • PURPOSE

    USE: Hair washing and scalp affected by exfoliation, scales and dry dandruff

  • KEEP OUT OF REACH OF CHILDREN

    This product must be keep out reach of children.

  • INDICATIONS & USAGE

    This product is for topical appplication. Wash the hair with the shampoo in the shower.
  • WARNINGS

    If this product is contact with eyes rinse immediately with water and consult your doctor

  • DOSAGE & ADMINISTRATION

    To wash daily during 8 or 10 weeks, soon interdaily use until the remission of the problem. This product is for topical application

  • INACTIVE INGREDIENT

    This composition moisturizes and lubricate capillary dermis

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL  IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SPAI-SONS   ALKALINE DRY-DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PONCEAU 4R (UNII: Z525CBK9PG)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-017-01210 mL in 1 BOTTLE
    2NDC:66854-017-02250 mL in 1 BOTTLE
    3NDC:66854-017-03400 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/30/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack
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