Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 72476-362-01, 72476-362-02
  • Packager: Retail Business Services, LLC
  • 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 July 24, 2023

If you are a consumer or patient please visit this version.

  • Disclaimer

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Head & Shoulders Pyrithione Zinc Dandruff Shampoo + Conditioner Coconut

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

  • Warnings

    For external use only

  • When using this product

    • do not get into 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 as directed
  • Keep out of reach 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, cocamidopropyl betaine, sodium xylenesulfonate, fragrance, amodimethicone, guar hydroxypropyltrimonium chloride, sodium benzoate, propylene glycol, citric acid, magnesium carbonate hydroxide, Cocos nucifera (coconut) fruit extract, hexyl cinnamal, benzyl salicylate, limonene, methylchloroisothiazolinone, methylisothiazolinone

  • Adverse Reactions

    DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

    SALISBURY, NC 28147

    For product questions or concerns, contact us at 1-833-922-3872

    Quality guaranteed or your money back

  • Principal Panel Display

    NDC 72476-362-02

    CAREONE

    Compaire to Head & Shoulders® Coconut 2 in 1 Dandruff Shampoo + Conditioner*

    2 IN 1 Coconut Dandruff Shampoo & Conditioner

    Dandruff Fighting Formula

    • Helps promote healthy hair and scalp
    • Pyrithione Zinc

    NET 12.5 FL OZ (370 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    2 IN 1 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-362
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    COCONUT (UNII: 3RT3536DHY)  
    HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-362-01420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    2NDC:72476-362-02370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/03/2023
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72476-362)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72476-362)