NDC 77397-102 Hand Sanitizer 70 Percent
Ethyl Alcohol Solution Topical

Product Information

Product Code77397-102
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Hand Sanitizer 70 Percent
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Ethyl Alcohol
Product Type 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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Ammmm, Inc.
Labeler Code77397
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-21-2020
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 77397-102-10

Package Description: 118 mL in 1 BOTTLE

NDC 77397-102-11

Package Description: 3785 mL in 1 BOTTLE

NDC 77397-102-12

Package Description: 236 mL in 1 BOTTLE

NDC 77397-102-13

Package Description: 354 mL in 1 BOTTLE

NDC 77397-102-14

Package Description: 500 mL in 1 BOTTLE

NDC 77397-102-15

Package Description: 1000 mL in 1 BOTTLE

Product Details

Hand Sanitizer 70 Percent is 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.


What are Hand Sanitizer 70 Percent Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)


* Please review the disclaimer below.

Hand Sanitizer 70 Percent Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Ethyl Alcohol 70%


Purpose



ANTIBACTERIAL


Function:



70% Alcohol Hand Sanitizers, kill 99.9% of the bacteria on hands with 2.5 ml of solution for 15 seconds after application.


Warnings



FOR EXTERNAL USE ONLY - HANDS

FLAMMABLE: KEEP 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 AND AVOID SWALLOW.

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 HANDS
  • RUB HANDS TOGETHER BRISKLY UNTIL DRY
  • NO RINSING REQUIRED
  • FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION
  • NOT RECOMMENDED FOR INFANTS

Inactive Ingredients



WATER, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL


Other Information:



  • DO NOT STORE ABOVE 105 (DEGREES FAHRENHEIT)
  • MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES
  • HARMFUL TO WOOD FINISHES AND PLASTICS

* Please review the disclaimer below.