NDC 45334-391 Vanicream Z-bar

Pyrithione Zinc

NDC Product Code 45334-391

NDC 45334-391-00

Package Description: 25 g in 1 BAG

NDC 45334-391-01

Package Description: 1 BAG in 1 CARTON > 100 g in 1 BAG

NDC Product Information

Vanicream Z-bar with NDC 45334-391 is a a human over the counter drug product labeled by Pharmaceutical Specialties, Inc.. The generic name of Vanicream Z-bar is pyrithione zinc. The product's dosage form is soap and is administered via topical form.

Labeler Name: Pharmaceutical Specialties, Inc.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vanicream Z-bar Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PYRITHIONE ZINC 2 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmaceutical Specialties, Inc.
Labeler Code: 45334
FDA Application Number: part358H What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vanicream Z-bar Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Mfr for PHARMACEUTICAL SPECIALTIES, INC., ROCHESTER, MN 55901800-325-8232www.vanicream.comMade in CanadaVanicream is a trademark, or registered trademark of Pharmaceutical Specialties, Inc. in the US or other countries.©PSI 2015. All rights reserved.

Otc - Active Ingredient

Active ingredientPyrithione zinc 2%

Otc - Purpose

PurposesAnti-dandruff,Anti-seborrheic dermatitis

Indications & Usage

UsesControls 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

  • DirectionsFor best results use at least twice a week or as directed by a doctorUse on affected areas in place of your regular soapWork up a rich lather using warm water and massage gently into affected areasRinse well

Storage And Handling

Other informationStore at room temperature

Inactive Ingredient

Inactive ingredientssodium 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

Otc - Questions

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

* Please review the disclaimer below.