NDC 62428-701 Alcohol Foaming Hand Sanitizer

Alcohol

NDC Product Code 62428-701

NDC 62428-701-03

Package Description: 750 mL in 1 BOTTLE

NDC 62428-701-29

Package Description: 1000 mL in 1 BAG

NDC 62428-701-53

Package Description: 50 mL in 1 BOTTLE

NDC 62428-701-57

Package Description: 550 mL in 1 BOTTLE

NDC Product Information

Alcohol Foaming Hand Sanitizer with NDC 62428-701 is a a human over the counter drug product labeled by Lawson Prodcuts, Inc. The generic name of Alcohol Foaming Hand Sanitizer is alcohol. The product's dosage form is soap and is administered via topical form.

Labeler Name: Lawson Prodcuts, Inc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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 Foaming 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 .62 mL/mL

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.

  • D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
  • WATER (UNII: 059QF0KO0R)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)

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: Lawson Prodcuts, Inc
Labeler Code: 62428
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: 03-14-2019 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: 12-31-2020 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 Foaming 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

Ethyk Alcohol 62%

Warnings

For external use only. Do not ingest.

FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.

Avoid contact with eyes. In case of eye contact, flush with large quantities of water, seek medical attention if irritation persists.

If skin irritation develops, discontinue use. If irritation persists for more than 72 hours, seek medical attention.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Water, Propylene Glycol, Acrylic Polymer, Alkyl Phosphate Salts, Fragrance, DC Green #5.

Purpose

Antiseptic

Alcohol Foaming Hand Sanitizer

KEEP OUT OF REACH OF CHILDREN

Directions

​Read the entire label before using this product.​Dispense 2 pumps of product onto palm of hand and rub thoroughly over all surfaces of both hands until dry.

Uses

Use hand sanitizer to reduce microorganisms on the skin.

Use this product when soap and water are not available.

* Please review the disclaimer below.

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