NDC 45334-305 Vanicream Anti-perspirant/deodorant

Aluminum Zirconium Trichlorohydrex Gly

NDC Product Code 45334-305

NDC CODE: 45334-305

Proprietary Name: Vanicream Anti-perspirant/deodorant What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aluminum Zirconium Trichlorohydrex Gly What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 45334 - Pharmaceutical Specialties, Inc.
    • 45334-305 - Vanicream Anti-perspirant/deodorant

NDC 45334-305-02

Package Description: 64 g in 1 CONTAINER

NDC Product Information

Vanicream Anti-perspirant/deodorant with NDC 45334-305 is a a human over the counter drug product labeled by Pharmaceutical Specialties, Inc.. The generic name of Vanicream Anti-perspirant/deodorant is aluminum zirconium trichlorohydrex gly. The product's dosage form is stick and is administered via topical form.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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 Anti-perspirant/deodorant 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.

  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HYDROGENATED POLY(C6-14 OLEFIN; 6 CST) (UNII: 3C785871IX)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: part350 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: 11-11-2016 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 Anti-perspirant/deodorant Product Label Images

Vanicream Anti-perspirant/deodorant 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

Otc - Active Ingredient

Active ingredientAluminum zirconium trichlorohydrex gly 20% (anhydrous)

Otc - Purpose

Purposeantiperspirant

Indications & Usage

  • Usesreduces underarm wetness24 hour extra effective protection

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use on broken skin

Otc - Ask Doctor

Ask a doctor before use if you have kidney disease

Otc - Stop Use

Stop use if
rash or irritation occurs

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

Directionsapply to underams only

Storage And Handling

Other informationStore at room temperature

Inactive Ingredient

Inactive ingredientscyclopentasiloxane, hydrogenated poly(C6-14 olefin), stearyl alcohol, phenyl trimethicone, hydrogenated castor oil, cetyl alcohol, silica

Otc - Questions

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

Other

Dist. by PHARMACEUTICAL SPECIALTIES, INC.Rochester, MN 55901 U.S.A.Made in Canada Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.

* Please review the disclaimer below.