NDC 77397-101 Hand Sanitizer 70 Percent

Ethyl Alcohol

NDC Product Code 77397-101

NDC 77397-101-11

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer 70 Percent with NDC 77397-101 is a a human over the counter drug product labeled by Ammmm, Inc.. The generic name of Hand Sanitizer 70 Percent is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Ammmm, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

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: Ammmm, Inc.
Labeler Code: 77397
FDA Application Number: part333E 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: 05-06-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

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 Label Images

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

ANTIBACTERIAL

Function:

70% ALCOHOL HAND SANITIZERS KILL MOST BACTERIA, AND FUNGI AND STOP SOME VIRUSES, KILL 99.9% OF THE BACTERIA ON HANDS 30 SECONDS AFTER APPLICATION AND 99.99% TO 99.999% IN ONE MINUTE.

Warnings

FOR EXTERNAL USE ONLYKEEP AWAY FROM HEAT, FIRE OR FLAME.WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH WITH THOROUGHLY WATER. AVOID CONTACT WITH BROKEN SKIN.STOP USE AND ASK A DOCTOR: IF IRRITATION OR REDNESS DEVELOPS OR IF CONDITION 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

  • APPLY AMOUNT OF SANITIZER IN YOUR PALM TO THOROUGHLY COVER YOUR HANDSRUB HANDS TOGETHER BRISKLY UNTIL DRYNO RINSING REQUIREDFOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION AND DON'T ALLOW THEM TO PUT THEIR HANDS IN THEIR MOUTH UNTIL THE PRODUCT EVAPORATES AND FEELS COMPLETELY DRY ON THE SKIN TO AVOID ACCIDENTAL INGESTIONNOT RECOMMENDED FOR INFANTS

Inactive Ingredients

AQUA, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, AMINOMETHYL PROPANOL

* Please review the disclaimer below.