NDC 50021-017 Sanitizer Wipes 70% Ethyl Alcohol

Alcohol

NDC Product Code 50021-017

NDC 50021-017-01

Package Description: 100 PACKET in 1 CANISTER > 5 mL in 1 PACKET

NDC 50021-017-02

Package Description: 180 PACKET in 1 CANISTER > 5 mL in 1 PACKET

NDC Product Information

Sanitizer Wipes 70% Ethyl Alcohol with NDC 50021-017 is a a human over the counter drug product labeled by Empack Spraytech Inc.. The generic name of Sanitizer Wipes 70% Ethyl Alcohol is alcohol. The product's dosage form is cloth and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1489307.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Sanitizer Wipes 70% Ethyl Alcohol 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.


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.

  • FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)
  • 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: Empack Spraytech Inc.
Labeler Code: 50021
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: 09-14-2021 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.

Sanitizer Wipes 70% Ethyl Alcohol Product Label Images

Sanitizer Wipes 70% Ethyl Alcohol 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

This is a hand sanitizer wipes with Alcohol 70% v/v.

Active Ingredient

Ethyl Alcohol 70% (v/v)

Purpose

Antiseptic

Uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease. • For use when soap and water are not available.

Warnings

For external use only.Flammability warning Keep away from open flame and sources of heat.

Otc - Do Not Use

Do not use • on children less than 2 months of age • on open skin wounds.

Otc - When Using

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Topical. If swallowed, call a poison control centre or get medical help right away.

Directions

• Adults and children over 2 years: • For occasional and personal domestic use • Supervise children under 6 years of age when using this product to avoid swallowing • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other Information

• Store at room temperature 15-30°C (59-86°F)

• Avoid freezing and extensive heat above 40°C (104°F)

Inactive Ingredients

Water, Fragrance

* Please review the disclaimer below.