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]

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)

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)

INGREDIENTS AND APPEARANCE

VANICREAM Z-BAR 
pyrithione zinc soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-390
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-390-33	1 in 1 CARTON	09/19/2016
1		95 g in 1 BAG; Type 0: Not a Combination Product
2	NDC: 45334-390-00	20 g in 1 CARTON; Type 0: Not a Combination Product	09/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/15/2016

Labeler - Pharmaceutical Specialties, Inc. (076499557)