NDC 75306-009 Psr Hand Sanitizer

Ethyl Alcohol

NDC Product Code 75306-009

NDC 75306-009-01

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC 75306-009-02

Package Description: 50 mL in 1 BOTTLE, SPRAY

NDC 75306-009-03

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC 75306-009-04

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC 75306-009-05

Package Description: 120 mL in 1 BOTTLE, SPRAY

NDC 75306-009-06

Package Description: 150 mL in 1 BOTTLE, SPRAY

NDC 75306-009-07

Package Description: 160 mL in 1 BOTTLE, SPRAY

NDC 75306-009-08

Package Description: 200 mL in 1 BOTTLE, SPRAY

NDC 75306-009-09

Package Description: 250 mL in 1 BOTTLE, SPRAY

NDC 75306-009-10

Package Description: 500 mL in 1 BOTTLE, SPRAY

NDC 75306-009-11

Package Description: 1000 mL in 1 BOTTLE, SPRAY

NDC 75306-009-12

Package Description: 3785 mL in 1 BOTTLE, SPRAY

NDC 75306-009-13

Package Description: 18927 mL in 1 BOTTLE, SPRAY

NDC 75306-009-14

Package Description: 5000 mL in 1 BOTTLE, SPRAY

NDC 75306-009-15

Package Description: 10000 mL in 1 BOTTLE, SPRAY

NDC 75306-009-16

Package Description: 15000 mL in 1 BOTTLE, SPRAY

NDC 75306-009-17

Package Description: 20000 mL in 1 BOTTLE, SPRAY

NDC Product Information

Psr Hand Sanitizer with NDC 75306-009 is a a human over the counter drug product labeled by D-time Limited Liability Company. The generic name of Psr Hand Sanitizer is ethyl alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: D-time Limited Liability Company

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Psr 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 80 ng/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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • APRICOT KERNEL OIL (UNII: 54JB35T06A)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • SODIUM PYRUVATE (UNII: POD38AIF08)

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: D-time Limited Liability Company
Labeler Code: 75306
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: 06-01-2020 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.

Psr Hand Sanitizer Product Label Images

Psr 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

Ethyl alcohol 80%

Purpose

Antiseptic skin cleanser

Uses

For personal hand hygiene to help prevent the spread of bacteria.

Warnings

For external use only. Flammable. Keep away from heat and flameWhen using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.Stop use and consult a healthcare professional if irritation develops.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children over 2 years:  For occasional and personal domestic use  Supervise children when they use this product ∙Spray onto hands and rub thoroughly for at least 30 seconds. Allow to dry

Inactive Ingredients

Water (Aqua), Glycerin, Apricot kernel oil, Bergamot leaf oil, Hydrogen peroxide, Sodium pyruvateOther informationStore at 68° to 70° F (20° to 25° C).May discolor certain fabrics or surfaces.Questions? 1-844-800-6858

* Please review the disclaimer below.