NDC 77617-015 Healthy Hands Plus

Ethyl Alcohol

NDC Product Code 77617-015

NDC 77617-015-01

Package Description: 1 L in 1 BOTTLE, PLASTIC

NDC 77617-015-02

Package Description: 1 L in 1 BOX

NDC Product Information

Healthy Hands Plus with NDC 77617-015 is a a human over the counter drug product labeled by Maintex. The generic name of Healthy Hands Plus is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Maintex

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.

Healthy Hands Plus 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 .7 L/L

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.

  • PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • 2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)
  • 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: Maintex
Labeler Code: 77617
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: 12-29-2020 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.

Healthy Hands Plus Product Label Images

Healthy Hands Plus 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 ...........70.0% v/v

Inactive Ingredients

Acrylates/Perfluorohexylethyl Methacrylate Copolymer, Glycerin, Isopropyl Alcohol, Perfluorohexylethyl Alcohol, Water

Purpose

Antiseptic

Uses

For hand sanitizing to decrease bacteria on the skin.recommended for repeated use.

Warnings

For external use only.

When Using This Product

- Avoid contact with eyes.- In case of eye contact, flush eyes with water.

Stop Use And Ask A Doctor If

-Irritation or redness develops, if condition persists for more than 72 hours.

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical helpor contact a Poison Control Center immediately.

Directions

-Pump a small amount of foam into palm of hand.  -Rub thoroughly over all surfaces of both hands.  -Rub hands together brisky until dry-Use between hand washings to help reduce germ tranmission

Healthy Hands

Healthy Hands1000mL


Box

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