NDC 62654-139 Csi E3 Hand Sanitizer

Alcohol

NDC Product Code 62654-139

NDC 62654-139-01

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC 62654-139-02

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 62654-139-37

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC 62654-139-38

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 62654-139-94

Package Description: 208197 mL in 1 DRUM

NDC Product Information

Csi E3 Hand Sanitizer with NDC 62654-139 is a a human over the counter drug product labeled by Central Solutions Inc. The generic name of Csi E3 Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Central Solutions Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Csi E3 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

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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: Central Solutions Inc
Labeler Code: 62654
FDA Application Number: part333E 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: 07-09-2020 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.

Csi E3 Hand Sanitizer Product Label Images

Csi E3 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

Active Ingredient

Ethanol 70%

Purpose

Antiseptic

Uses

An effective antimicrobial hand cleanser for topical applicationRecommended for repeated useReduces transient microorganisms on intact skinKeep hands from drying out due to repeated uses

Warnings

For External Use Only.Flammable, keep away from fire or opem flame

Otc - When Using

When using this product:Avoid contact with eyesIn case of eye contact, flush with water for 15 minutes

Otc - Stop Use

Discontinue use and see a doctor if irritation occursAvoid contact with broken skin

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Wet hands thoroughly with product.Allow to dry without wiping.Use no water or towels

Other Information

Not tested on animals

Inactive Ingredients

Purified Water, Glycerin

Questions?

Call 800-255-0262

* Please review the disclaimer below.