Label: EVERY MAN JACK 2-IN-1 ANTI-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 December 17, 2021

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  • ACTIVE INGREDIENT

    PYRITHIONE ZINC  1%

  • PURPOSE

    ANTI DANDRUFF

  • USE

    • FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF AND SEBORRHEIC DERMATITIS , AND TO HELP PREVENT THEIR RECURRENCE.
  • WARNINGS

    FOR EXTERNAL USE ONLY.ASK A DOCTOR BEFORE USE IF YOU HAVE

    • ABORRHEIC DERMATITIS IN AREAS OTHER THAN SCALP.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH 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 OF THIS PRODUCT AS DIRECTED.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDRN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • SHAMPOO, THEN RINSE THOROUGHLY.
    • FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR ASDIRECTED BY A DOCTOR.
  • INACTIVE INGREDIENTS

    WATER/AQUA/EAU, AMMONIUM LAURYL SULFATE, SODIUM COCO-SULFATE, DECYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, QUATERNIUM 80, GLYCOL STEARATE, DIMETHICONE COPOLYOL, CETRIMONIUM CHLORIDE, PEG-30 CASTOR OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, TOCOPHERYL ACETATE (VITAMIN E), HYDROLYZED WHEAT PROTEIN,CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, PANTHENOL (VITAMIN B5), CITRIC ACID, BENZYL ALCOHOL, CARAMEL, COUMARIN, LINALOOL, EUCALYPTUS GLOBULUS (EUCALYPTUS) OIL, MENTHA ARVENSIS (CORNMINT) OIL, MENTHA VIRDIS (SPEARMINT) LEAF OIL, FRAGRANCE/PARFUM.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_EMJ_2-in-1 Anti-Dandruff Shampoo-Conditioner

  • INGREDIENTS AND APPEARANCE
    EVERY MAN JACK 2-IN-1 ANTI-DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57934-5011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARAMEL (UNII: T9D99G2B1R)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    QUATERNIUM-82 (UNII: AFS70NB1WJ)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PEG-30 CASTOR OIL (UNII: GF873K38RZ)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57934-5011-3400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/16/2019
    Labeler - EVERY MAN JACK (013586921)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVERSIFIED MANUFACTURING CORP185073996manufacture(57934-5011)
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