Label: HEAD AND SHOULDER MEN OLD SPICE- pyrithione zinc lotion/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 16, 2015

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  • ACTIVE INGREDIENT

    DRUGS FACTS

    ACTIVE INGREDIENTS

    Pyrithione zinc 1%

  • PURPOSE

    PURPOSE

    Anti-dandruff

  • USER SAFETY WARNINGS

    USES

    Help prevent recurrence of flaking and itching associated with dan druff

  • WARNINGS

    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 procuct as directed.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a poison control center rigth away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • for best results use at least twice a week or as directed by doctor.
    • for maximun dandruff control, use every time you shampoo
    • shake bedore use
    • wet hair, message onto scalp, rinse, repeat if desired.
  • INACTIVE INGREDIENT

    WATER, SODIUM LAURYL SULFATE, SODIUM LAURETH SULDATE, GLYCOL DISTEARATE , ZINC CARBONATE, SODIUM CHLORIDE, SODIUM XYLENESULFONATE, COCAMIDOPROPYL BETAINE, FRAGANCE, DIMETHICONE, SODIUM BENZOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1, RED 33

  • PRINCIPAL DISPLAY PANEL

    pyrithione zincHEAD AND SHOULDERS MEN OLD SPICE

  • INDICATIONS & USAGE

    HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDER  MEN OLD SPICE
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-102
    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)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-102-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2015
    2NDC:69772-102-02700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2015
    3NDC:69772-102-03400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2015
    4NDC:69772-102-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2015
    5NDC:69772-102-05200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/16/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA Genesis078760958relabel(69772-102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter and Gamble Manufacturara SA De CV812807550manufacture(69772-102)
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