Label: ASSURED- 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 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Pyrithione 1%

  • PURPOSE

    Purpose

    Anti-dandruff

  • INDICATIONS & USAGE

    Use

    • helps prevent recurrence of flaking and itching associated with dandruff.
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use as directed.
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well.
    • wet hair.
    • massage into 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.
  • STORAGE AND HANDLING

    Other information

    • store at 20°C (69° to 77°F)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Glycol Distearate, Sodium Chloride, Fragrance, Citric Acid, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY

    CHESAPEAKE, VA 23320

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    ASSURED™

    Dandruff Shampoo

    Dry Scalp Care

    MOISTURIZING

    RELIEVES

    DRYNESS • ITCHING • FLAKING

    13.5 FL OZ (400 mL)

    Assured Dandruff Shampoo

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0700
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0700-1400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/19/2017
    Labeler - Greenbrier International Inc. (610322518)
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