VANICREAM Z-BAR- pyrithione zinc soap

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]

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
• 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 INGREDIENT

Inactive ingredients sodium cocoyl isethionate, stearic acid, coconut acid, sodium isethionate, water, 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

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

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

Made in the USA with US and select imported materials

PRINCIPAL DISPLAY PANEL

VANICREAM™ Z-Bar

Pyrithione Zinc 2%

NDC: 45334-392-35

DERMATOLOGIST TESTED

Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar

for Sensitive Skin

Net Wt 3.5 oz (99g)

INGREDIENTS AND APPEARANCE

VANICREAM Z-BAR 
pyrithione zinc soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-392
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
PROPANEDIOL (UNII: 5965N8W85T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PEG-30 STEARATE (UNII: 1U8KB35S20)
WATER (UNII: 059QF0KO0R)
COCONUT ACID (UNII: 40U37V505D)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SORBIC ACID (UNII: X045WJ989B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM ISETHIONATE (UNII: 3R36J71C17)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-392-35	99 g in 1 CARTON; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	10/01/2024

Labeler - Pharmaceutical Specialties, Inc. (076499557)