NDC 63517-803 Roll On Anti-perspirant (alcohol Free)

Aluminum Chlorohydrate

NDC Product Code 63517-803

NDC 63517-803-45

Package Description: 45 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Roll On Anti-perspirant (alcohol Free) with NDC 63517-803 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Roll On Anti-perspirant (alcohol Free) is aluminum chlorohydrate. The product's dosage form is solution and is administered via topical form.

Labeler Name: Cardinal Health

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Roll On Anti-perspirant (alcohol Free) 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 CHLOROHYDRATE 10 g/100mL

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)
  • HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EDETATE SODIUM (UNII: MP1J8420LU)

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: Cardinal Health
Labeler Code: 63517
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: 09-04-2013 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.

Roll On Anti-perspirant (alcohol Free) Product Label Images

Roll On Anti-perspirant (alcohol Free) 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

For external use only.

Distributed by: Cardinal Health Waukegan, IL 60085 USA

Active Ingredient

Aluminum Chlorohydrate 10% - Anhydrous Basis

Purpose

Antiperspirant

Use

Reduces underarm wetness.

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 immediately. Use only as directed.

Directions

Apply to underarms only.

Inactive Ingredients

Fragrance, Glycerin, Hydroxyethylcellulose, Polysorbate 20, Purified Water, Tetrasodium EDTA

* Please review the disclaimer below.