Label: MARCS DRY SCALP CARE DANDRUFF 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 January 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 of this product as directed

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    ⬥
    shake well
    ⬥
    wet hair
    ⬥
    massage onto scalp
    ⬥
    rinse
    ⬥
    repeat if desired
    ⬥
    for best results use at least twice a week or as directed by a doctor
    ⬥
    for maximum dandruff control, use every time you shampoo
  • Inactive ingredients

    water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, glycol distearate, dimethicone, fragrance, prunus amygdalus dulcis (sweet almond) oil, cetyl alcohol, polyquaternium-10, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Marc Glassman, Inc.
    West 130th Street
    Cleveland, OH 44130

  • PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label

    *Compare to the active
    ingredient in Head & Shoulders®

    Marcs®

    pyrithione zinc

    Dandruff
    Shampoo

    Dry Scalp Care

    Moisturizing formula for
    dryness & itch relief

    pyrithione zinc 1 %

    05-1928B

    13.5 FL OZ (399 mL)

    PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MARCS DRY SCALP CARE DANDRUFF   ANTI-DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-133
    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 LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)  
    AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Sodium Xylenesulfonate (UNII: G4LZF950UR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-133-01399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/04/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H10/04/2013
    Labeler - Mark Glassman, Inc. (094487477)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(68998-133)
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