Label: VANICREAM- pyrithione zinc shampoo

  • NDC Code(s): 45334-206-07, 45334-206-08
  • Packager: Pharmaceutical Specialties, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Pyrithione zinc 2%

  • PURPOSE

    Purposes

    Anti-dandruff,

    Anti-seborrheic dermatitis

  • INDICATIONS & USAGE

    Uses

    Controls and reduces the symptoms of dandruff and seborrheic dermatitis

  • WARNINGS

    Warnings

    For external use only

    Ask a doctor before use if you have a condition that covers a large area of the body.

    When using this product avoid contact with the 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • For best results use at least twice a week or as directed by a doctor
    • Shake before use
    • Wet hair and massage gently into scalp
    • Leave lather on scalp for several minutes
    • Rinse well, repeat if needed
  • STORAGE AND HANDLING

    Other information

    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients purified water, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride

  • QUESTIONS

    Questions?

    1-800-325-8232

    www.vanicream.com

  • SPL UNCLASSIFIED SECTION

    Dist. by

    PHARMACEUTICAL SPECIALTIES, INC.

    ROCHESTER, MN 55901 • Made in U.S.A.

    www.vanicream.com • 1-800-325-8232

  • PRINCIPAL DISPLAY PANEL

    NDC 45334-206-08

    Formerly known as Free & Clear™

    VANICREAM™

    Pyrithione Zinc 2%

    Dandruff Shampoo

    for Sensitive Skin

    DERMATOLOGIST TESTED

    Free of dyes, fragrance, masking fragrance, lanolin, protein, parabens, & formaldehyde releasers

    Sulfate-free • Betaine-free • Gluten-free

    8 fl oz (237 mL)

    45334-206 Dandruff Shampoo

  • INGREDIENTS AND APPEARANCE
    VANICREAM 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    WATER (UNII: 059QF0KO0R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45334-206-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2022
    2NDC:45334-206-077.4 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/03/2022
    Labeler - Pharmaceutical Specialties, Inc. (076499557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Specialties, Inc.076499557manufacture(45334-206)
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