NDC 81776-204 Medama Foam Hand Sanitizer

Ethanol

NDC Product Code 81776-204

NDC 81776-204-01

Package Description: 1000 mL in 1 CONTAINER

NDC Product Information

Medama Foam Hand Sanitizer with NDC 81776-204 is a a human over the counter drug product labeled by Ace Janitorial Supply Co., Inc.. The generic name of Medama Foam Hand Sanitizer is ethanol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ace Janitorial Supply Co., Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Medama Foam 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 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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Ace Janitorial Supply Co., Inc.
Labeler Code: 81776
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: 04-13-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Medama Foam Hand Sanitizer Product Label Images

Medama Foam 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

Other

Drug Facts

Medama Solutions1365 62st Street, Brooklyn, New York, 11219P 718.492.7200 • F 718.492.3878MADE IN THE USA

Otc - Active Ingredient

Active IngredientEthyl Alcohol 70% v/v

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • UsesFor handwashing to decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment.Recommended for repeated use.

Warnings

  • WarningsFor external use only.

Otc - When Using

  • Keep out of eyes, ears, or mouth.

Otc - Stop Use

  • Discontinue use if irritation occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Other Safety Information

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

Dosage & Administration

  • DirectionsIf hands are visibly soiled, wash with soap and water and dry hands.Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Inactive Ingredients

Benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.

* Please review the disclaimer below.