Label: PERT PLUS 2 IN 1 SHAMPOO AND CONDITIONER DRY SCALP CARE- pyrithione zinc shampoo, suspension

  • 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 May 31, 2012

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  • SPL UNCLASSIFIED SECTION

    Pert Plus 2 in 1 Shampoo & Conditioner Dry Scalp Care
    for moisturizing and relieving scalp itch
    Great hair should be simple
    Use daily: 1. Wet 2. Lather 3. Rinse.
    MM1
  • Active Ingredient

    Active Ingredient

    Pyrithione Zinc 1.0%

  • Purpose:

    Anti-Dandruff

  • Uses

    Controls the symptoms of dandruff.

  • 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 best results, use at least twice a week or as directed by a doctor. Gently massage into wet hair, lather and rinse. Repeat if desired.
  • Inactive Ingredients

    Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, dimethicone, cetyl alcohol, cocamide MEA, sodium chloride, fragrance, guar hydroxypropyltrimonium chloride, hydrogenated polydecene, sodium citrate, sodium benzoate, polyquaternium 10, PEG-7M, trimethylolpropane tricaprylate/tricaprate, citric acid, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, ammonium xylene sulfonate, Yellow 10, Blue 1.

  • Questions or Comments?

    1-800-487-7273
    www.pertplus.com

    Idelle Labs, Ltd. All rights reserved.
    Made in Canada. Distributed by Idelle Labs, Ltd., El Paso, TX 79912

  • PRINCIPAL DISPLAY PANEL

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    label

  • INGREDIENTS AND APPEARANCE
    PERT PLUS 2 IN 1 SHAMPOO AND CONDITIONER  DRY SCALP CARE
    pyrithione zinc shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41595-6503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
    TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41595-6503-1400 mL in 1 BOTTLE
    2NDC:41595-6503-2750 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H06/01/2012
    Labeler - Idelle Labs, Ltd (128822926)
    Registrant - Idelle Labs, Ltd (128822926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Body Blue 2006 Inc.243094112MANUFACTURE
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