NDC 77331-001 No-wash Antibacterial

Ethanol

NDC Product Code 77331-001

NDC 77331-001-01

Package Description: 500 mL in 1 BOTTLE

NDC 77331-001-02

Package Description: 20 mL in 1 BOTTLE

NDC 77331-001-03

Package Description: 30 mL in 1 BOTTLE

NDC 77331-001-04

Package Description: 40 mL in 1 BOTTLE

NDC 77331-001-05

Package Description: 50 mL in 1 BOTTLE

NDC 77331-001-06

Package Description: 60 mL in 1 BOTTLE

NDC 77331-001-07

Package Description: 80 mL in 1 BOTTLE

NDC 77331-001-08

Package Description: 100 mL in 1 BOTTLE

NDC 77331-001-09

Package Description: 120 mL in 1 BOTTLE

NDC 77331-001-10

Package Description: 250 mL in 1 BOTTLE

NDC 77331-001-11

Package Description: 300 mL in 1 BOTTLE

NDC 77331-001-12

Package Description: 1000 mL in 1 BOTTLE

NDC 77331-001-13

Package Description: 2000 mL in 1 BOTTLE

NDC 77331-001-14

Package Description: 5000 mL in 1 BOTTLE

NDC Product Information

No-wash Antibacterial with NDC 77331-001 is a a human over the counter drug product labeled by Majestic Group Llc. The generic name of No-wash Antibacterial is ethanol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Majestic Group Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

No-wash Antibacterial 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 75 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)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Majestic Group Llc
Labeler Code: 77331
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: 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.

No-wash Antibacterial Product Label Images

No-wash Antibacterial 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

Purpose

Antimicrobial

Uses

Hand-Sanitizer helps to reduce the amount of disease causing bacteria on the skin

Warnings

  • Flammable. Keep away from fire or flame.For external use only.Do not use this hand sanitizer  on or near the eyes.In case of accidental contact, flush eyes thoroughtly with water.Do not use on broken skin: Do not inhale or ingest.In case of skin irritation please stop use and talk to doctor.

Directions

  • Place enough product in your palm to thoroughly cover your hands. Rub hands togerher thoroughly until dry.For children under 6 years old use only under adult supevision :Not recommended for use on infants.

Keep Out Of Reach Of Children

If accidentally  swallowed,  contact the  Poison Control Center or get medical help immediately.

Other Information

  • Do not store above 110°F (43°C)May discolor certain fabrics or surfaces

Inactive Ingredient

Water(Aqua),Carbomer,Glycerin,Triethanolamine

* Please review the disclaimer below.