Label: SIMPLY CLEAN DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 55910-153-15, 55910-153-32, 55910-153-35, 55910-153-86
  • Packager: Old East Main Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Claims

    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Relieve irritation
    • Soothe and reduce redness
    • Reduce oilness
    • Prevent flakes
    • Leave hair healthy looking
  • Acitive 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, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • Disclaimer

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders® Classic Clean Dandruff Shampoo.

  • Adverse reactions

    DISTRIBUTED BY OLD EAST MAIN CO.

    1OO MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100%

    Satisfaction

    Guaranteed!

    (888)309-9030

  • Principal display panel

    STUDIO SELECTION

    SIMPLY CLEAN

    DANDRUFF SHAMPOO

    PYRITHIONE ZINC 1%

    Compare to Head & Shoulders® Classic Clean Dandruff Shampoo*

    For normal or oily hair

    pH balanced formula

    PARABEN - PHTHALATE FREE

    12.5 FL OZ (370 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SIMPLY CLEAN DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-153
    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:55910-153-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    2NDC:55910-153-35700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    3NDC:55910-153-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    4NDC:55910-153-32369.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03202/15/1995
    Labeler - Old East Main Co. (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-153)
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