Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 55910-921-15, 55910-921-32
  • Packager: Old East Main Co.
  • 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 August 22, 2023

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  • Claims

    • Fight dry scalp
    • Clam itch
    • Relieve irritation
    • Soothe and reduce redness
    • Reduce oiliness
    • Prevent flakes
    • Leave hair healthy looking
  • Active Ingreidnet 

    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, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, butylphenyl methylpropional, limonene, linalool, blue 1, red 33

  • Adverse Reaction

    100% Satisfaction Guaranteed!

    (888) 309-9030

    DISTRIBUTED BY OLD MAIN CO.

    100 MISSION RIDGE 

    GOODLETTSVILLE, TN 37072

  • Principal Panel Display

    STUDIO SELECTION

    FOR MEN

    SANDAL WOOD

    DANDRUFF SHAMPOO + CONDITIONER

    PYRITHIONE ZINC 15

    Helps relieve dryness, itching & light flaking

    2in1

    Paraben Phthalate Free

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    2 IN 1 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-921
    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)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-921-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2023
    2NDC:55910-921-32369.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/06/2023
    Labeler - Old East Main Co. (068331990)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-921)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-921)
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