NDC 63533-855 Han-i-foam

Alcohol

NDC Product Code 63533-855

NDC Code: 63533-855

Proprietary Name: Han-i-foam 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.

Non-Proprietary Name: Alcohol 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.

NDC Code Structure

  • 63533 - Momar Incorporated
    • 63533-855 - Han-i-foam

NDC 63533-855-08

Package Description: 1 BAG in 1 BOX > 1000 mL in 1 BAG

NDC 63533-855-10

Package Description: 1000 mL in 1 CARTRIDGE

NDC 63533-855-11

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 63533-855-12

Package Description: 1000 mL in 1 BAG

NDC 63533-855-17

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Han-i-foam with NDC 63533-855 is a a human over the counter drug product labeled by Momar Incorporated. The generic name of Han-i-foam is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Momar Incorporated

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.

Han-i-foam 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 .62 mL/mL

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)

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: Momar Incorporated
Labeler Code: 63533
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: 07-10-2019 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: 12-31-2020 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.

Han-i-foam Product Label Images

Han-i-foam 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

Drug Facts Box Otc-Active Ingredient Section

Ethyl Alcohol 62% v/v

Drug Facts Box Otc-Purpose Section

Antiseptic

Drug Facts Box Otc-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box Otc-Warnings Section

FLAMMABLE, keep away from fire and flamesFor external use only

Drug Facts Box Otc-When Using Section

Do not get into eyesif contact occurs, rinse eyes thoroughly with water

Drug Facts Box Otc-Stop Use Section

Irritation and redness develop

Drug Facts Box Otc-Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box Otc-Dosage & Administration Section

Press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your handrub hands together and allow to dry without wiping

Drug Facts Box Otc-Inactive Ingredient Section

Water, DEA-C8-18 perfluoroalkylethyl phosphate, propylene glycol, fragrance

Han-I-Foam 6585 50 Ml

6585Z1Q610.jpg Han-I-Foam 50ml

* Please review the disclaimer below.

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