Label: PERSONAL CARE PYRITHIONE ZINC 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 29, 2016

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  • Drug FactsActive ingredient

    Pyrithione Zinc 1%                          

  • Purpose

    Anti-dandruff

  • Use

     helps prevent recurrence of flaking and itching associated with dandruff.

  • Warning

    For external use only.

  • When using this product

     do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

     condition worsens or does not improve after regular use as directed.

  • Keep out of reach of children.

     If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • wet hair
    • massage shampoo into scalp
    • rinse
    • repeat if desired
    • for best results, use at least twice a week or as directed by a doctor
    • for maximum dandruff control, use every time you shampoo.
  • Inactive Ingredients

    water (aqua), sodium laureth sulfate,  sodium lauryl sulfate, cocamide MEA, sodium chloride, dimethicone, cetyl alcohol, polyquaternium-10, glycol distearate, disodium EDTA, cocamidopropyl betain, DMDM hydantoin, citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone,  methylisothiazolinone, FD and C Blue 1

  • Personal Care Dry Scalp Dandruff Shampoo

    Personal  Care

    eucalyptus

    DRY SCALP

    Pyrithione Zinc

    Dandruff

    Shampoo

    helps relieve itching & flaking while moisturizing to help

    PREVENT DRYNESS

    13.5 FL OZ (400 mL)

    Distributed by:

    Personal Care Products, LLC

    Troy, Michigan 48084

    U.S.A.

    Made in China

    PC Dandruff Dry 2216

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE PYRITHIONE ZINC DANDRUFF  
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC4.04 g  in 400 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2216-0400 mL in 1 BOTTLE; Type 0: Not a Combination Product01/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/07/2011
    Labeler - Personal Care Products, LLC (966155082)
    Registrant - Personal Care Products, LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd530766098manufacture(29500-2216)
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