Label: ANTI-DANDRUFF SHAMPOO AND CONDITIONER HOWL- pyrithione zinc lotion/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 March 8, 2010

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  • ACTIVE INGREDIENT

    Pyrithione Zinc 1% ............. (Antidandruff)

  • USES

    To help prevent recurrence of flaking and itching associated with dandruff

  • WARNINGS

    For external use only

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    • Condition worsens or does not improve after regular use of this product as directed

    WHEN USING THIS PRODUCT

    • Avoid contact with eyes
    • If contact occurs, rinse eyes throughly with water

    KEEP OUT OF REACH OF CHILDREN

    • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately
  • PACKAGE FRONT AND BACK LABELS

    • 12 OZ FRONT AND BACK LABELS: blade12.jpg
      12OZ FRONT AND BACK LABELS
  • INGREDIENTS AND APPEARANCE
    ANTI-DANDRUFF SHAMPOO AND CONDITIONER  HOWL
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-422
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.0000 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-422-12355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35803/08/2010
    Labeler - Apollo Health and Beauty Care (201901209)
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