NDC 54913-020 Sweatblock

Aluminum Zirconium Tetrachlorohydrex Gly

NDC Product Code 54913-020

NDC 54913-020-76

Package Description: 76 g in 1 CONTAINER

NDC Product Information

Sweatblock with NDC 54913-020 is a a human over the counter drug product labeled by Dc Alpine Partners, Llc. The generic name of Sweatblock is aluminum zirconium tetrachlorohydrex gly. The product's dosage form is stick and is administered via topical form.

Labeler Name: Dc Alpine Partners, Llc

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.

Sweatblock 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.

  • ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g

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-8 DISTEARATE (UNII: 7JNC8VN07M)
  • PPG-14 BUTYL ETHER (UNII: R199TJT95T)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

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: Dc Alpine Partners, Llc
Labeler Code: 54913
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: 02-11-2021 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: 12-31-2022 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 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.

Sweatblock Product Label Images

Sweatblock 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

Clinical Protection

Deodorant + Antiperspirant

SWEATBLOCKCOASTAL FRESHDeodorant +Antiperspirant48HOUR

Active Ingredient

Aluminum Zirconium Tetrachlorohydrex Gly (20%)

Purpose

Antiperspirant

Use

Reduces underarm wetness

Warnings

For external use only.

Do Not Use

On broken skin.

Stop Use If

Rash or irritation occurs.

Ask A Doctor Before Use If

You have kidney disease.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center immediately.

Directions

Apply to underarms only.

Inactive Ingredients

Cyclopentasiloxane, Fragrance, Hydrogenated Castor Oil, Isopropyl Myristate, PEG-8 Distearate, PPG-14 Butyl Ether, Silica, Stearyl Alcohol

Questions?

Call toll free 1-855-796-2566

Distributed By:

SweatBlockAlpine, UT 84004, USA855-796-2566www.sweatblock.com

* Please review the disclaimer below.