NDC 45334-206 Vanicream

Pyrithione Zinc

NDC Product Code 45334-206

NDC 45334-206-07

Package Description: 7.4 mL in 1 TUBE

NDC 45334-206-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Vanicream with NDC 45334-206 is a a human over the counter drug product labeled by Pharmaceutical Specialties, Inc.. The generic name of Vanicream is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 244458.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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 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.


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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
  • SUCROSE COCOATE (UNII: 3H18P0UK73)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
  • WATER (UNII: 059QF0KO0R)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: 01-03-2022 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Vanicream 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

Dist. byPHARMACEUTICAL SPECIALTIES, INC.ROCHESTER, MN 55901 • Made in U.S.A.www.vanicream.com • 1-800-325-8232

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

WarningsFor 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 doctorShake before useWet hair and massage gently into scalpLeave lather on scalp for several minutesRinse well, repeat if needed

Storage And Handling

Other informationStore at room temperature

Inactive Ingredient

Inactive ingredients purified water, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride

Otc - Questions

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

* Please review the disclaimer below.