VANICREAM Z-BAR (PYRITHIONE ZINC) SOAP [PHARMACEUTICAL SPECIALTIES, INC.]

VANICREAM Z-BAR (PYRITHIONE ZINC) SOAP [PHARMACEUTICAL SPECIALTIES, INC.]
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NDC 45334-390-00, 45334-390-33
Set ID 34b357f5-8567-2815-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Specialties, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
  • 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 DOCTOR

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

  • WHEN USING

    When using this product avoid contact with the 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 of this product 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

    • For best results use at least twice a week or as directed by a doctor
    • Use on affected areas in place of your regular soap
    • Work up a rich lather using warm water and massage gently into affected areas
    • Rinse well
  • STORAGE AND HANDLING

    Other information

    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    sodium cocoyl isethionate, stearic acid, sodium stearate, water, sodium lauroyl sarcosinate, paraffin, petrolatum, sorbitol, cetearyl alcohol, propanediol, ceteareth-20, simethicone, glyceryl stearate, PEG-30 stearate, sorbic acid

  • QUESTIONS

    Questions?

    1-800-325-8232

    www.vanicream.com

  • SPL UNCLASSIFIED SECTION

    VANICREAM™ Z-Bar

    Pyrithione Zinc 2%

    Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar

    • Helps relieve itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis.
    • Mild and gentle
    • Non-comedogenic
    • Contains Vanicream™ Cream Base
    • Gluten-free
    • For face, hands, body & scalp
  • SPL UNCLASSIFIED SECTION

    For information on our other products for sensitive skin, call 800-325-8232 or visit our website at www.vanicream.com.

    Official Vanicream • vanicream

    Mfr for PHARMACEUTICAL SPECIALTIES, INC., ROCHESTER, MN 55901

    800-325-8232

    www.vanicream.com

    Made in U.S.A.

    Vanicream is a trademark, or registered trademark of Pharmaceutical Specialties, Inc. in the US or other countries.

    ©PSI2015. All rights reserved.

  • PRINCIPAL DISPLAY PANEL

    NDC 45334-390-33

    DERMATOLOGIST TESTED

    VANICREAM™ Z-Bar

    Pyrithione Zinc 2%

    Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar

    Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde

    for Sensitive Skin

    Net Wt 3.36 oz (95 g)

    Outside box

    NDC 45334-390-00

    DERMATOLOGIST TESTED

    VANICREAM™ Z-Bar

    Pyrithione Zinc 2%

    Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar

    Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde

    for Sensitive Skin

    Net Wt 0.7 oz (20 g)

    Small size box

  • INGREDIENTS AND APPEARANCE
    VANICREAM Z-BAR 
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-30 STEARATE (UNII: 1U8KB35S20)  
    SORBITOL (UNII: 506T60A25R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45334-390-331 in 1 CARTON09/19/201608/31/2022
    195 g in 1 BAG; Type 0: Not a Combination Product
    2NDC:45334-390-0020 g in 1 CARTON; Type 0: Not a Combination Product09/15/201610/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/15/201608/31/2022
    Labeler - Pharmaceutical Specialties, Inc. (076499557)

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