NDC 81934-101 Hypochlorous Acid Hand Sanitizer

Hypochlorous Acid

NDC Product Code 81934-101

NDC CODE: 81934-101

Proprietary Name: Hypochlorous Acid Hand Sanitizer 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: Hypochlorous Acid 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

  • 81934 - Shenzhen Risai Medical Technology Co., Ltd

NDC 81934-101-05

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Hypochlorous Acid Hand Sanitizer with NDC 81934-101 is a a human over the counter drug product labeled by Shenzhen Risai Medical Technology Co., Ltd. The generic name of Hypochlorous Acid Hand Sanitizer is hypochlorous acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Shenzhen Risai Medical Technology 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.

Hypochlorous Acid Hand Sanitizer 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.

  • HYPOCHLOROUS ACID 50 mg/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.

  • 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: Shenzhen Risai Medical Technology Co., Ltd
Labeler Code: 81934
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-25-2021 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.

Hypochlorous Acid Hand Sanitizer Product Label Images

Hypochlorous Acid Hand Sanitizer 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

Hypochlorous acid 100 mg/L. Purpose: Sanitation.

Purpose

Kill germs and viruses, keep hands sanitated, protect health from disease or pandmics.

Use

Hand disinfection for medical staff, or hand sanitation of families, enterprise or public places. It's suitable as well for hand sanitation of children, women and aged people.

Warnings

For external use only.Do not use for eyes disinfection.Keep out of reach of children.

Do Not Use

Do not use for eyes disinfection.

Cautions

The product is normally not irritation to human skin or mucosa. If you feel uncomfortable in case of contact of eyes, please rinse or clean it with water. If swallowed and fee unwell, please get medical help.

Stop Use

If you feel uncomfortable in case of contact of eyes, please rinse or clean it with water. If swallowed and fee unwell, please get medical help.

Keep Out Of Reach Of Children

Keep out of reach of children.

Method To Use

Press the nozzle to soak the hand, keep rubbing hands for 1 minute.

Storage

Keep away from heat and sunlight.Store in room temperature and in cool place.

Inactive Ingredient

Water

* Please review the disclaimer below.