NDC 63798-821 Bio-strike Antiperspirant/deodorant

Aluminum Zirconium Trichlorohydrex Gly

NDC Product Code 63798-821

NDC CODE: 63798-821

Proprietary Name: Bio-strike Antiperspirant/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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 63798 - Hunters Specialties, Inc.
    • 63798-821 - Bio-strike Antiperspirant/deodorant

NDC 63798-821-02

Package Description: 56.66 g in 1 CANISTER

NDC Product Information

Bio-strike Antiperspirant/deodorant with NDC 63798-821 is a a human over the counter drug product labeled by Hunters Specialties, Inc.. The generic name of Bio-strike Antiperspirant/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.

Bio-strike Antiperspirant/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.

  • WATER (UNII: 059QF0KO0R)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • TALC (UNII: 7SEV7J4R1U)
  • GLYCINE (UNII: TE7660XO1C)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SILVER NITRATE (UNII: 95IT3W8JZE)

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: Hunters Specialties, Inc.
Labeler Code: 63798
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: 08-15-2017 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 - 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.

Bio-strike Antiperspirant/deodorant Product Label Images

Bio-strike Antiperspirant/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

Other

Drug Facts

Distributed by Hunters Specialties, Inc.[6000 Huntington Ct, NE]Cedar Rapids , IA 52402

Active Ingredient

Aluminum Zirconium Trichlorohydrex Gly 20%

Purpose

Anti-perspirant

Use

Reduces underarm wetness. Extra effective.

Warnings

For external use only. Do not use on broken skin. Ask a doctor before use if you have a kidney disease. 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.

Directions

Turn dial 2 clicks to raise product. Apply to underarms only.

Other Information

Avoid storage at extreme temperatures (below 35˚F and above 115˚F).

Inactive Ingredients

Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Castor Oil, Talc, Dimethicone, Polyethylene, Water, Sodium Borate, Silver Nitrate.

* Please review the disclaimer below.