Label: DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 72476-311-15, 72476-311-32, 72476-311-35, 72476-311-40, view more
    72476-311-86
  • Packager: Retail Business Services, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • Disclaimer

    *This product is not manufactured or distributed by Procter & Gamble, distributer of Head & Shoulders® Classic Clean 2in1 Dandruff Shampoo + Conditioner.

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    Helps prevent recurrence or flaking and itching associated with dandruff

  • Warnings

    for external use only

  • When using this product

    • do not get into eyes. If contact occures, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • condition worsens or does not improve after regular use as directed
  • Keep out of each of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • 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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • Adverse reactions

    DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

    SALISBURY, NC 28147

    For product questions or concerns, contact us at 1-833-992-3872

    Quality guaranteed or your money back.

  • principal display panel

    CAREone®

    Compare to Head & Shoulders® Classic Clean Dandruff Shampoo + Conditioner*

    2IN1

    EVERYDAY CLEAN

    DANDRUFF SHAMPOO & CONDITIONER

    Dandruff Fighting Formula

    • Moisturizes to help relieve dry scale
    • Pyrithione Zinc

    12.5 FL OZ (370 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-311-32370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    2NDC:72476-311-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    3NDC:72476-311-40612 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    4NDC:72476-311-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2023
    5NDC:72476-311-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03202/15/1995
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72476-311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72476-311)
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