Label: HALSA PYRITHIONE ZINC DANDRUFF - DRY SCALP CARE - pyrithione zinc shampoo

  • NDC Code(s): 75884-200-01
  • Packager: Momentum Brands dba 99 Cents Only Stores
  • 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 January 7, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Pyrithione Zinc 1%                           Anti-dandruff

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  • PURPOSE

    Purpose

    Anti-dandruff

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  • INDICATIONS & USAGE

    Use helps prevent recurrence of flaking and itching associated with dandruff.

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  • WARNINGS

    Warnings

    For external use only.

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  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    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.

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  • INACTIVE INGREDIENT

    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

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  • DESCRIPTION

    This product is not manufactured or distributed by

    Procter and Gamble, the distributor of Head and Shoulders


    Manufactured in China

    Exclusively for and Distributed by:

    Personal Care Products, Inc.

    Bingham Farms, MI 48025-2463


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  • PRINCIPAL DISPLAY PANEL

    Halsa

    Pyrithione Zinc

    Dandruff

    Shampoo


    Compare to the

    Active Ingredients of

    Head and Shoulders



    dry scalp care

    moisturizes to help prevent dry skin

    helps to relieve itching dryness and flaking.


    13.5 FL. OZ. (400 mL)


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  • INGREDIENTS AND APPEARANCE
    HALSA PYRITHIONE ZINC DANDRUFF - DRY SCALP CARE 
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:75884-200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75884-200-01 400 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/07/2011
    Labeler - Momentum Brands dba 99 Cents Only Stores (094435237)
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