NDC 51072-112 Hand Sanitizer

Hand Sanitizer

NDC Product Code 51072-112

NDC 51072-112-00

Package Description: 946 mL in 1 BOTTLE

NDC 51072-112-01

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 51072-112 is a a human over the counter drug product labeled by Jefferson Labs. The generic name of Hand Sanitizer is hand sanitizer. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 582753.

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.

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.


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.

  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)

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: Jefferson Labs
Labeler Code: 51072
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: 04-06-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 05-31-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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".

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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

Drug Facts

Active IngredientEthyl Alcohol 70%

Purpose

Antiseptic

Uses

  • To help reduce bacteria on the skin that could cause diseaserecommended for repeated use

Warnings

  • For external use only: handsFlammable. Keep away from fire or flame.When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skindo not inhale or ingestStop use and ask a doctor ifirritation and redness developscondition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For 946 mL bottleuse to refill a pump bottle. From the pump bottle apply a small amount onto hands, rub thoroughly with product and allow to dry without wipingdo not use on children less than 2 months of agenot recommended for infantsFor 473 mL bottlewet hands thoroughly with product and allow to dry without wipingdo not use on children less than 2 months of agenot recommended for infants

Other Information

  • Store between 20–25° C (68–77° F). Avoid excessive heat above 40° C (104° F).may discolor some fabricsharmful to wood finishes and plastics

Inactive Ingredients

Citrate Buffer, Glycerin, Hydroxyethyl Cellulose, Isopropyl Alcohol, PEG, Water

Other

MANUFACTURED BY:Aurora Pharmaceutical, Inc.NORTHFIELD, MINNESOTA 55057888-215-1256MADE IN THE USA

* Please review the disclaimer below.