NDC 81820-001 Handout Protection Hand Sanitizer

Isopropyl Alcohol Liquid

NDC Product Code 81820-001

NDC 81820-001-01

Package Description: 1 mL in 1 POUCH

NDC 81820-001-02

Package Description: 2 mL in 1 POUCH

NDC 81820-001-03

Package Description: 3 mL in 1 POUCH

NDC 81820-001-04

Package Description: 4 mL in 1 POUCH

NDC 81820-001-05

Package Description: 5 mL in 1 POUCH

NDC 81820-001-06

Package Description: 6 mL in 1 POUCH

NDC 81820-001-07

Package Description: 7 mL in 1 POUCH

NDC 81820-001-08

Package Description: 8 mL in 1 POUCH

NDC 81820-001-09

Package Description: 9 mL in 1 POUCH

NDC 81820-001-10

Package Description: 10 mL in 1 POUCH

NDC 81820-001-11

Package Description: 30 mL in 1 BOTTLE

NDC 81820-001-12

Package Description: 50 mL in 1 BOTTLE

NDC 81820-001-13

Package Description: 60 mL in 1 BOTTLE

NDC 81820-001-14

Package Description: 100 mL in 1 BOTTLE

NDC 81820-001-15

Package Description: 150 mL in 1 BOTTLE

NDC 81820-001-16

Package Description: 180 mL in 1 BOTTLE

NDC 81820-001-17

Package Description: 200 mL in 1 BOTTLE

NDC 81820-001-18

Package Description: 236 mL in 1 BOTTLE

NDC 81820-001-19

Package Description: 250 mL in 1 BOTTLE

NDC 81820-001-20

Package Description: 300 mL in 1 BOTTLE

NDC 81820-001-21

Package Description: 350 mL in 1 BOTTLE

NDC 81820-001-22

Package Description: 400 mL in 1 BOTTLE

NDC 81820-001-23

Package Description: 450 mL in 1 BOTTLE

NDC 81820-001-24

Package Description: 500 mL in 1 BOTTLE

NDC 81820-001-25

Package Description: 1000 mL in 1 BOTTLE

NDC 81820-001-26

Package Description: 2000 mL in 1 BOTTLE

NDC Product Information

Handout Protection Hand Sanitizer with NDC 81820-001 is a a human over the counter drug product labeled by Zhejiang Sairui Medical Technology Co., Ltd.. The generic name of Handout Protection Hand Sanitizer is isopropyl alcohol liquid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Zhejiang Sairui 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.

Handout Protection 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.

  • ISOPROPYL ALCOHOL 75 mL/100mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)

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: Zhejiang Sairui Medical Technology Co., Ltd.
Labeler Code: 81820
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: 03-26-2021 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.

Handout Protection Hand Sanitizer Product Label Images

Handout Protection 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

Otc - Active Ingredient

Isoproply Alcohol 75% v/v………………Antiseptic

Otc - Keep Out Of Reach Of Children

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

Otc - Do Not Use

  • In children less than 2 months of age.On open skin wounds.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Otc - Purpose

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

Otc - When Using

Keep out of eyes, mouth in case of contact with eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Dosage & Administration

  • Place product on hands to cover all surfaces. Rub hands together untill dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive Ingredient

Aloe gel, condensed green tea, glycerine, hydrogen peroxide

Otc - Stop Use

If irritation or rash occurs. They may be signs of a serious condition.

Indications & Usage

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

* Please review the disclaimer below.