Label: DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 55301-153-15, 55301-153-21, 55301-153-32
  • Packager: Your Military Exchanges
  • 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 September 15, 2023

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  • Claims

    Multiple benefit formula to help:

    • Fight dry scalp
    • Calm itch
    • Relieve irritation
    • Reduce oiliness
    • Soothe and reduce redness
    • Prevent flakes
    • Leave hair healthy looking
  • 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 maxmum dandruff controll, 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

    "SATISFACTION GUARANTEED OR YOUR MONEY BACK."

    Manufactured For Your

    Military Exchanges

    By: Vi-Jon, 8515 Page Avenue

    St. Louis, MO 63114

  • Principal display panel

    Compare to the active ingredient on Head & Shoulders® Classic Clean Dandruff Shampoo*

    exchange select

    EVERYDAY CLEAN

    DANDRUFF SHAMPOO

    PYRITHIONE ZINC

    DANDRUFF SHAMPOO

    FOR NORMAL/OILY HAIR

    pH balanced formula

    quality

    value

    12.5 FL OZ

    (370 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-153
    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:55301-153-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/1999
    2NDC:55301-153-2188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/1999
    3NDC:55301-153-32370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/26/1999
    Labeler - Your Military Exchanges (001695568)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55301-153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55301-153)
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