Label: HEAD AND SHOULDERS 2 IN 1 SMOOTH AND SILKY- pyrithionr 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 April 19, 2017

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  • ACTIVE INGREDIENT

    DRUG FACTS

    ACTIVE INGREDIENTE

    Pyrithione Zinc 1%

  • PURPOSE

    PURPOSE

    Anti-drandruff

  • USER SAFETY WARNINGS

    USES

    Help prevent recurrence of flaking and itching associated with dandruff

  • 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 product 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 right away

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • For maximun drandruff contral, 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 INGREDIENT

    Water, soium laureth sulfate, sodium lauryl sulfate, dimethicone, cocamide MEA, zinc carbonate, glycoldistearate, sodium xylenesulfonate, fragance, cethyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, methylchloroisothiazolinone, methlylisothiazolinone.

  • SPL UNCLASSIFIED SECTION

    Made in Mexico By:

    Procter and Gamble

    #69772

  • INDICATIONS & USAGE

    FOR EXTERNAL USE ONLY

    FOR BEST RESULT USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

  • PRINCIPAL DISPLAY PANEL

    Head &Shoulder

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  2 IN 1 SMOOTH AND SILKY
    pyrithionr zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-324-68200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2015
    2NDC:69772-324-14420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2015
    3NDC:69772-324-23700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2015
    4NDC:69772-324-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/13/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA Genesis078760958relabel(69772-324)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufacturera S. De R.L. De C.V.812807550manufacture(69772-324)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roir SA de CV812825434relabel(69772-324)
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