Vanicream Z-Bar by Pharmaceutical Specialties, Inc. VANICREAM™ Z-Bar

Vanicream Z-Bar by

Drug Labeling and Warnings

Vanicream Z-Bar by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VANICREAM Z-BAR- pyrithione zinc soap 
Pharmaceutical Specialties, Inc.

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.

----------

VANICREAM™ Z-Bar

Drug Facts

Active ingredient

Pyrithione zinc 2%

Purposes

Anti-dandruff,

Anti-seborrheic dermatitis

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

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.

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

Other information

Store at room temperature

Inactive ingredients

sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, sodium cocoyl glycinate, sodium chloride, petrolatum, sorbitol, cetearyl alcohol, propanediol, ceteareth-20, simethicone, glyceryl stearate, PEG-30 stearate, sorbic acid

Questions? 1-800-325-8232 www.vanicream.com

Dist. by PHARMACEUTICAL SPECIALTIES, INC., ROCHESTER, MN 55901

1-800-325-8232

www.vanicream.com

Made in Canada

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

©PSI 2015. All rights reserved.

SH21B

NDC: 45334-391-01

DERMATOLOGIST TESTED

VANICREAM™ Z-Bar

Pyrithione Zinc 2%

Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar

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

Gluten-Free

for Sensitive Skin

Net Wt 3.53 oz (100 g)

label

VANICREAM Z-BAR 
pyrithione zinc soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 45334-391
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
COCONUT ACID (UNII: 40U37V505D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 45334-391-011 in 1 CARTON01/01/202101/31/2024
1100 g in 1 BAG; Type 0: Not a Combination Product
2NDC: 45334-391-0025 g in 1 BAG; Type 0: Not a Combination Product01/01/202111/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03201/01/202101/31/2024
Labeler - Pharmaceutical Specialties, Inc. (076499557)

Revised: 2/2023