NDC 73893-004 Ivogel Hand Sanitizer

Antiseptic Gel

NDC Product Code 73893-004

NDC 73893-004-01

Package Description: 59.1 mL in 1 BOTTLE, DISPENSING

NDC 73893-004-02

Package Description: 236.6 mL in 1 BOTTLE, DISPENSING

NDC 73893-004-03

Package Description: 473.2 mL in 1 BOTTLE, DISPENSING

NDC 73893-004-04

Package Description: 295.7 mL in 1 BOTTLE, DISPENSING

NDC 73893-004-05

Package Description: 946.4 mL in 1 BOTTLE, DISPENSING

NDC 73893-004-06

Package Description: 3800 mL in 1 CONTAINER

NDC 73893-004-07

Package Description: 9500 mL in 1 CONTAINER

NDC 73893-004-08

Package Description: 18900 mL in 1 CONTAINER

NDC 73893-004-09

Package Description: 113600 mL in 1 DRUM

NDC 73893-004-10

Package Description: 189300 mL in 1 DRUM

NDC 73893-004-11

Package Description: 59.1 mL in 1 TUBE

NDC 73893-004-12

Package Description: 354.9 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Ivogel Hand Sanitizer with NDC 73893-004 is a a human over the counter drug product labeled by Plasmadent Inc. The generic name of Ivogel Hand Sanitizer is antiseptic gel. The product's dosage form is gel and is administered via topical form.

Labeler Name: Plasmadent Inc

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.

Ivogel Hand Sanitizer 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

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: Plasmadent Inc
Labeler Code: 73893
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: 10-23-2020 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.

Ivogel Hand Sanitizer Product Label Images

Ivogel Hand Sanitizer 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

Nova Gel

Advanced Hand Sanitizer
Original ScentLeaves Hands Feeling Soft8 FL OZ (236.6 mL)

Active Ingredient

Active Ingredient PurposeEthyl Alcohol 70% v/v ----------------Antiseptic

Purpose

Use- To decrease bacteria on the skin

Use

Use-To decrease bacteria on the skin

Keep Out Of The Reach Of Children

Keep out of the reach of children

Warnings

WarningsFlammable. Keep away from fire or flame.For external use onlyWhen using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stope use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed get medical help or contact a poisen control center right away.

Directions

Directions-wet hands thoroughly with product and allow to dry without wiping. For children under 6 use only under adult supervision. Not recommended for infants.

Other Information

Other information- Do not store above 110
oF (43
oC)
May discolor some fabrics. Harmful to wood finishes and plastics

Inactive Ingredient Section

Inactive Ingredient- Water, Glycerin, Carbomer, Aminomethyl propanol, fragrance

* Please review the disclaimer below.