NDC 53074-003 75% Ethanol Disinfectant (washing-free)

Instant Hand Disinfectant (ethanol75%)

NDC Product Code 53074-003

NDC CODE: 53074-003

Proprietary Name: 75% Ethanol Disinfectant (washing-free) 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: Instant Hand Disinfectant (ethanol75%) 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

  • 53074 - Zhejiang Anji Huabu Industrial Co., Ltd
    • 53074-003 - 75% Ethanol Disinfectant (washing-free)

NDC 53074-003-01

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

75% Ethanol Disinfectant (washing-free) with NDC 53074-003 is a a human over the counter drug product labeled by Zhejiang Anji Huabu Industrial Co., Ltd. The generic name of 75% Ethanol Disinfectant (washing-free) is instant hand disinfectant (ethanol75%). The product's dosage form is liquid and is administered via extracorporeal form.

Labeler Name: Zhejiang Anji Huabu Industrial Co., Ltd

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.

75% Ethanol Disinfectant (washing-free) 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 375 mL/500mL

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Extracorporeal - Administration outside of the body.
  • Extracorporeal - Administration outside of the body.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Zhejiang Anji Huabu Industrial Co., Ltd
Labeler Code: 53074
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: 05-29-2020 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.

75% Ethanol Disinfectant (washing-free) Product Label Images

75% Ethanol Disinfectant (washing-free) 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

Dosage & Administration

Store in a cool, dry and ventilated place.

Inactive Ingredient

WATER

Indications & Usage

1.Sanitize hands: Evenly spray or apply the disinfectant to the hand once or twice with the action time of about 1 minutes to achieve the disinfection effect. Surgical hand disinfectant wipe 2 times, with the action time of about 3 minutes to achieve the disinfectioneffect.

2. Skin disinfection:evenl spray the disinfectant or rub it on the skin surface 2 times,with the action time of about 3 minutes to achieve the disinfection effect.

3.surface disinfection: spray the stock solution on the surface of the object, keep it wet or wipe the surface of the object 2 times, a sound sterilization will be achieved within 5 minutes.

Otc - Active Ingredient

ALCOHOL

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

Disinfection

Sterilization

Warnings

1. This product is a topical disinfectant and should not be taken orally.

2. Place the product out of reach of children.

3. Inflammable, keep away from fire source.

4. Store the product in a cool, dark and dry place.

5. This product is not suitable for disinfection of fat-soluble surfaces.

* Please review the disclaimer below.