Label: HEAD AND SHOULDERS BREAKAGE PREVENTION- pyrithione zinc shampoo

  • NDC Code(s): 51769-141-01, 51769-141-05, 51769-141-11, 51769-141-18, view more
    51769-141-20, 51769-141-40, 51769-141-50
  • Packager: ALL NATURAL DYNAMICS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Pyrithione zinc 1%

    Purpose

    Anti-dandruff

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  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

    helps prevent hair loss

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  • Warnings

    For external use only.

    When using this product

    • avoid contact with 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 of this product as directed.

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

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

    Water, Sodium laureth sulfate, Sodium lauryl sulfate, Coco Monoethanolamide, Zinc carbonate, Glycol distearate, Dimethicone, Guar hydroxypropyltrimonium chloride, Magnesium sulfate, Sodium benzoate, Magnesium carbonate hydroxide, Benzyl alcohol, Tocopheryl acetate, FD&C Yellow No. 5, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue no. 1

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  • Questions (or comments)?

    01-800-717-2413

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  • SPL UNCLASSIFIED SECTION

    Dist. by

    Procter & Gamble Manufactura, S. de R.L. de C.V.

    San Andr`s Atoto No. 326, Naucalpan de Juarez,

    Estado de Mexico, MX

    www.headandshoulders.com

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  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  BREAKAGE PREVENTION
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51769-141
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pyrithione Zinc (PYRITHIONE ZINC) Pyrithione Zinc 0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Sodium laureth sulfate  
    Sodium lauryl sulfate  
    Coco Monoethanolamide  
    Zinc carbonate  
    Glycol distearate  
    Dimethicone  
    Guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)  
    Magnesium sulfate  
    Sodium benzoate  
    magnesium carbonate hydroxide  
    Benzyl alcohol  
    .ALPHA.-TOCOPHEROL ACETATE  
    FD&C Yellow No. 5  
    methylchloroisothiazolinone  
    methylisothiazolinone  
    FD&C Blue no. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51769-141-50 500 mL in 1 BOTTLE, PLASTIC
    2 NDC:51769-141-40 400 mL in 1 BOTTLE, PLASTIC
    3 NDC:51769-141-20 200 mL in 1 BOTTLE, PLASTIC
    4 NDC:51769-141-11 1000 mL in 1 BOTTLE, PLASTIC
    5 NDC:51769-141-18 1180 mL in 1 BOTTLE, PLASTIC
    6 NDC:51769-141-05 50 mL in 1 BOTTLE, PLASTIC
    7 NDC:51769-141-01 10 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 02/01/2013
    Labeler - ALL NATURAL DYNAMICS (962732892)
    Establishment
    Name Address ID/FEI Business Operations
    Procter & Gamble Manufactura, S. de R.L. de C.V. 812807550 manufacture(51769-141)
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