NDC 77838-116 Prosanca

70% Ethanol

NDC Product Code 77838-116

NDC 77838-116-15

Package Description: 500 mL in 1 BOTTLE

NDC 77838-116-16

Package Description: 1000 mL in 1 BOTTLE

NDC Product Information

Prosanca with NDC 77838-116 is a a human over the counter drug product labeled by Proem Group. The generic name of Prosanca is 70% ethanol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Proem Group

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Prosanca 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

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: Proem Group
Labeler Code: 77838
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: 01-15-2021 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 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.

Prosanca 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

Otc - Active Ingredient

Alcohol 70% Purpose Antiseptic

Inactive Ingredient

Water, Glycerin, Hydrogen peroxide

Warnings

For external use only, Flammable, Keep away from heat or flam.Do not use: in children less 2 months of age on open skin woundsWhen use this product: this product keep out of eyes,ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash occurs, these may be signs of s serious conditionKeep out of reach of children. If swallow get medical or contact of poison Control Center right away

Indications & Usage

Hand Sanitizer to help reduce bateria that potentially can cause disease for use when soap are not available

Otc - Keep Out Of Reach Of Children

If swallow, get medical help or contact o poison control Center right away.

Dosage & Administration

70% Ethanol alcohol

Otc - Purpose

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap are not avalble.

* Please review the disclaimer below.