NDC 75586-101 Instant Hand Sanitizer

75% Alcohol

NDC Product Code 75586-101

NDC 75586-101-01

Package Description: 30 mL in 1 BOTTLE

NDC 75586-101-03

Package Description: 60 mL in 1 BOTTLE

NDC 75586-101-05

Package Description: 100 mL in 1 BOTTLE

NDC 75586-101-06

Package Description: 120 mL in 1 BOTTLE

NDC 75586-101-07

Package Description: 150 mL in 1 BOTTLE

NDC 75586-101-10

Package Description: 200 mL in 1 BOTTLE

NDC 75586-101-13

Package Description: 250 mL in 1 BOTTLE

NDC 75586-101-15

Package Description: 300 mL in 1 BOTTLE

NDC 75586-101-25

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Instant Hand Sanitizer with NDC 75586-101 is a a human over the counter drug product labeled by Dongyang Mukang Pharmaceutical Factory. The generic name of Instant Hand Sanitizer is 75% alcohol. The product's dosage form is gel and is administered via extracorporeal form.

Labeler Name: Dongyang Mukang Pharmaceutical Factory

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Instant 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.

  • 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Dongyang Mukang Pharmaceutical Factory
Labeler Code: 75586
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: 05-01-2020 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.

Instant Hand Sanitizer Product Label Images

Instant 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(S)

Ethanol 75% v/v. Purpose: Antiseptic

Purpose

Hand sanitizer to help decrease bacteria skin.

Use

Take a proper amount and put it on the palm directly. Rub the fingers of both hands on each other until the skin of hands and wrists is completely wet. It will work for 1-3 minutes and evaporate naturally. Not sticky use. No need to wash with water, protecting your health anytime, anywhere.

Warnings

1. Flammable, please keep away from the fire source, store in a cool, dry and ventilated place.

2. Use with caution for alcohol-allergic people.

3. Not suitable for disinfecting the surface of fat soluble objects.

4. Keep out of reach of children.

Do Not Use

1. Not sticky use. 2. Use with caution for alcohol-allergic people.

3. Not suitable for disinfecting the surface of fat soluble objects.

Otc - When Using

This product is for external use, no taken orally, avoid contact with eyes.

Otc - Stop Use

If there is skin irritation, please stop using. If further irritation, please consult a doctor and keep it below.

Otc - Keep Out Of Reach Of Children

Keep away from reach of children.

Directions

Take a proper amount and put it on the palm directly. Rub the fingers of both hands on each other until the skin of hands and wrists is completely wet. It will work for 1-3 minutes and evaporate naturally. Not sticky use. No need to wash with water, protecting your health anytime, anywhere.

Other Information

Store at a cool place, avoid sunlight.

Inactive Ingredients

Purified water, Triethanolamine, Glycerin, Carbomer.

* Please review the disclaimer below.