Label: CRAWFORD 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 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione zinc 0.5%

  • PURPOSE

    Purpose

    Anti dandruff

  • INDICATIONS & USAGE

    Uses

    helps prevent recurrence of flaking and itching associated with dandruff.

  • WARNINGS

    Warnings using this product
    For external use only.

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

  • DOSAGE & ADMINISTRATION

    Directions: For maximum dandruff control, use at least twice a week. Wet hair, massage through hair and scalp, rinse and repeat if desired.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Glycol Distearate, Cocamidopropyl Betaine, Polyquaternium-7, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue #1

  • SPL UNCLASSIFIED SECTION

    Manufactured for

    Crawford Supply • St. Louis, MO 63132

    PRODUCT OF CANADA

  • PRINCIPAL DISPLAY PANEL

    Crawford

    Dandruff Shampoo

    Clears Hair of Dandruff Flakes

    4 fl. oz. (118 mL)

    Crawford Dandruff Shampoo

  • INGREDIENTS AND APPEARANCE
    CRAWFORD DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-009-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/18/2019
    Labeler - Brands International (243748238)
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