NDC 51384-003 Alcohol Based Hand Sanitizer Total Pure

Hand Sanitizer

NDC Product Code 51384-003

NDC 51384-003-01

Package Description: 1000 mL in 1 BOTTLE

NDC 51384-003-02

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Alcohol Based Hand Sanitizer Total Pure with NDC 51384-003 is a a human over the counter drug product labeled by Botanicals Internacional S.a. De C.v.. The generic name of Alcohol Based Hand Sanitizer Total Pure is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Botanicals Internacional S.a. De C.v.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Alcohol Based Hand Sanitizer Total Pure 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.

  • ALCOHOL 70 mL/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.

  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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.
  • 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: Botanicals Internacional S.a. De C.v.
Labeler Code: 51384
FDA Application Number: part333A 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-29-2020 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 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.

Alcohol Based Hand Sanitizer Total Pure 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

1000Ml Active Ingredient

1000 ML NDC: 51384-003-01

1000Ml Keep Out Of Reach Section

1000ML NDC: 51384-003-01

1000Ml Purpose

1000ML NDC: 51384-003-01

1000Ml Warnings And Precaution

1000ML NDC: 51384-003-01

1000Ml Dosage And Admin.

1000ML NDC: 51384-003-01

1000Ml Indications And Usage

1000ML NDC: 51384-003-01

1000Ml Warning Section

1000ML NDC: 51384-003-01

500Ml Active Ingedient.

500ML NDC: 51384-003-02

500Ml Purpose

500ML NDC: 51384-003-02

500Ml Warinings And Precautions

500ML NDC: 51384-003-002

500Ml Dosage And Administration

500ML NDC: 51384-003-02

500Ml Indications And Usage Section

500ML NDC: 51384-003-02

500Ml Warnings

500ML NDC: 51384-003-02

1000Ml Inactive Ingredients

1000ML NDC: 51384-003-01

500Ml Inactive Ingredients

500ML NDC: 51384-003-02

1000Ml Front Display

1000ML NDC: 51384-003-01

500Ml Front Label Display

500ML NDC: 51384-003-002

* Please review the disclaimer below.