NDC 75780-013 Meineke Instant Hand Sanitizer With Moisturizer Formula

Alcohol

NDC Product Code 75780-013

NDC CODE: 75780-013

Proprietary Name: Meineke Instant Hand Sanitizer With Moisturizer Formula 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: Alcohol 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

  • 75780 - Ningbo Meineke Biotech Technology Co., Ltd.

NDC 75780-013-01

Package Description: 237 mL in 1 BOTTLE

NDC 75780-013-02

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Meineke Instant Hand Sanitizer With Moisturizer Formula with NDC 75780-013 is a a human over the counter drug product labeled by Ningbo Meineke Biotech Technology Co., Ltd.. The generic name of Meineke Instant Hand Sanitizer With Moisturizer Formula is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ningbo Meineke Biotech 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.

Meineke Instant Hand Sanitizer With Moisturizer Formula 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 70 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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)

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.
  • 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: Ningbo Meineke Biotech Technology Co., Ltd.
Labeler Code: 75780
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: 07-09-2020 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.

Meineke Instant Hand Sanitizer With Moisturizer Formula Product Label Images

Meineke Instant Hand Sanitizer With Moisturizer Formula 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

Active ingredient                                  PurposeEthyl Alcohol                70%      ...        Antiseptic

Otc - Purpose

Antiseptic

Warnings

  • For external use only.Flammable. Keep away from fire or flame.Do not apply around eyes. Do not use in ears and mouth.When using this products, avoid contact with eyes. In case of contact, flush eyes with water.Stop using and ask a doctor, if redness and irritation develop and persist for more than 72 hours.Other information: store at 68℉-77℉ (20℃)may discolor some fabricsharmful to wood finishe and plastics

Otc - Keep Out Of Reach Of Children

Children must be supervised in use of this product.

Dosage & Administration

  • Wet hands thoroughly with product and allow to dry without wiping For children under 6, use only under adult supervisionNot recommended for infants

Inactive Ingredient

Water, Triethanolamine, Glycerin, propylene glycol, Carbomer

* Please review the disclaimer below.