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 Facts Active Ingredient

    Pyrithione Zinc 1%   

  • Purpose

    Anti-dandruff

  • Keep out of reach of children.

    Keep out of reach of children.

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

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    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.

  • 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, polyquaternium-7,
    glycol distearate, disodium EDTA, cocamidopropyl betain, DMDM hydantoin guar hydropropyltrimonium chloride,
    citric acid, fragrance, benzyl alcohol, methylchloroisothiazolinone,  methylisothiazolinone, FD and C Blue #1.

  • Personal care Dandruff Shampoo

    Personal  Care®

    fresh ocean

    DAILY CLEAN

    Pyrithione Zinc

    Dandruff
    Shampoo

    helps to relieve itching,
    dryness & flaking for

    ALL HAIR TYPES


    13.5 FL. OZ. (400 mL)


    Distributed by:
    Personal Care Products, LLC
    Troy, Michigan  48025

    U.S.A.

    Made in China

    PC Dandruff 6000

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE PYRITHIONE ZINC DANDRUFF  
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-6000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-6000-1400 mL in 1 BOTTLE; Type 0: Not a Combination Product01/22/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/22/2010
    Labeler - Personal Care Products, Inc. (966155082)
    Registrant - Personal Care Products, Inc. (603124298)
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