Otc - Active Ingredient
Active ingredient
pyrithione zinc 2%
Vanicream Z-bar Soap
FDA Label NDC 45334-392
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmaceutical Specialties, Inc. for the product Vanicream Z-bar (NDC 45334-392). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if you have a condition that covers a large area of the body.
Otc - When Using
When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Otc - 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
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
Otc - Questions
Questions? 1-800-325-8232 www.vanicream.com
Other
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
Package Label.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)
* Please review the disclaimer below.
