Label: HEAD AND SHOULDERS BREAKAGE PREVENTION- 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 February 1, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1%

    Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

    helps prevent hair loss

  • 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.

  • 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.
  • 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

  • Questions (or comments)?

    01-800-717-2413

  • 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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  BREAKAGE PREVENTION
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51769-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium laureth sulfate (UNII: BPV390UAP0)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    Coco Monoethanolamide (UNII: C80684146D)  
    Zinc carbonate (UNII: EQR32Y7H0M)  
    Glycol distearate (UNII: 13W7MDN21W)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) (UNII: B16G315W7A)  
    Magnesium sulfate (UNII: DE08037SAB)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    magnesium carbonate hydroxide (UNII: YQO029V1L4)  
    Benzyl alcohol (UNII: LKG8494WBH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    FD&C Blue no. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51769-141-50500 mL in 1 BOTTLE, PLASTIC
    2NDC:51769-141-40400 mL in 1 BOTTLE, PLASTIC
    3NDC:51769-141-20200 mL in 1 BOTTLE, PLASTIC
    4NDC:51769-141-111000 mL in 1 BOTTLE, PLASTIC
    5NDC:51769-141-181180 mL in 1 BOTTLE, PLASTIC
    6NDC:51769-141-0550 mL in 1 BOTTLE, PLASTIC
    7NDC:51769-141-0110 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/01/2013
    Labeler - ALL NATURAL DYNAMICS (962732892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufactura, S. de R.L. de C.V.812807550manufacture(51769-141)
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