NDC 50518-307 Hand Sanitizer 70 Percent

Ethyl Alcohol

NDC Product Code 50518-307

NDC 50518-307-11

Package Description: 240 mL in 1 BOTTLE

NDC 50518-307-12

Package Description: 480 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer 70 Percent with NDC 50518-307 is a a human over the counter drug product labeled by Custom Research Labs Inc. The generic name of Hand Sanitizer 70 Percent is ethyl alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Custom Research Labs Inc

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.

Hand Sanitizer 70 Percent 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)

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: Custom Research Labs Inc
Labeler Code: 50518
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: 07-17-2020 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.

Hand Sanitizer 70 Percent 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 70%

Purpose

ANTIMICROBIAL

Uses

  • FOR HANDWASHING TO DECREASE MICROBIAL CONTAMINATION ON THE SKINMAY BE REAPPLIED DURING THE DAY AS REQUIRED

Warnings

FOR EXTERNAL USE ONLY. DO NOT DRINK.FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME.DO NOT USE IN THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER, THEN CONTACT PHYSICIAN.STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP AND 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

  • WET HANDS THOROUGHLY WITH PRODUCTBRISKLY RUB HANDS TOGETHER UNTIL DRYSUPERVISE CHILDREN UNDER 6 YEARS IN THE USE OF PRODUCTWET THE SURFACE WITH THE SPRAY. ALLOW TO AIR DRY. NO RINSING OR WIPING REQUIRED.

Other Information

  • STORE AT 20°C TO 25°C (68°F TO 77°F)MAY DISCOLOR SOME FABRICS

Inactive Ingredients

PURIFIED WATER/AQUA/EAU PURIFIE, GLYCERIN

* Please review the disclaimer below.