NDC 78539-001 Alcohol Based Hand Sanitizer

NDC Product Code 78539-001

NDC 78539-001-02

Package Description: 59.14 mL in 1 BOTTLE

NDC 78539-001-04

Package Description: 118.29 mL in 1 BOTTLE

NDC 78539-001-08

Package Description: 236.5 mL in 1 BOTTLE

NDC 78539-001-16

Package Description: 473.17 mL in 1 BOTTLE

NDC 78539-001-32

Package Description: 1890 mL in 1 BOTTLE

NDC 78539-001-64

Package Description: 3780 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Alcohol Based Hand Sanitizer with NDC 78539-001 is product labeled by Seattle Sanitizer Llc. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Seattle Sanitizer Llc
Labeler Code: 78539
Start Marketing Date: 03-30-2020 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Alcohol Based 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(S)

Ethyl Alcohol 85% v/v

Purpose

Antiseptic

Use(S)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from heat or flame.Do not use• on children less than 2 months of age• on open skin woundsWhen using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)Denatured Alcohol, Ethyl Alcohol 85% as determined by hydrometer.

* Please review the disclaimer below.