Label: EVERYDAY CLEAN DANDRUFF- pyrithione zinc shampoo

  • 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 18, 2020

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  • claims

    Dandruff Care for Great Looking Hair

    This product helps relieve scalp dryness, itch,

    irritation and helps prevent flakes.

    Clean Manageable Hair Everyday

    • Keep hair clean and manageable
    • Gentle and pH balanced for everyday use-even for permed or color treated hair
  • active ingredient

    Pyrithione zinc 1%

    Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

  • Warning

    For external use only

    When using this product

    • do not get into eyes.  If contact occurs, rinse eyes throughly 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

  • Adverse reactions

    DISTRIBUTED BY:

    CHAIN DRUG CONSORTIUM, LLC

    3301 N.W. BOCA RATON BLVD, SUITE 101

    BOCA RATON, FL 33431

    153.008/153AZ rev 1

  • principal display panel

    Compare to the Active Ingredient in Head & Shoulders

    Premier Vlaue

    everyday clean

    dandruff

    shampoo

    Everyday Basic

    Cleaning

    Normal/Oily

    Hair

    Pyrithione Zinc

    Dandruff Shampoo

    Premier Value Guarantee

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    EVERYDAY CLEAN DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-153
    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:68016-153-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/05/2001
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(68016-153)
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