NDC 52174-012 Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe

Alcohol

NDC Product Code 52174-012

NDC CODE: 52174-012

Proprietary Name: Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe 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

  • 52174 - Ningbo Bst Clean And Care Products Co., Ltd
    • 52174-012 - Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe

NDC 52174-012-01

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe with NDC 52174-012 is a a human over the counter drug product labeled by Ningbo Bst Clean And Care Products Co., Ltd. The generic name of Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ningbo Bst Clean And Care Products Co., Ltd

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.

Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe 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 71 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER 934 (UNII: Z135WT9208)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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.

  • 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 Bst Clean And Care Products Co., Ltd
Labeler Code: 52174
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: 05-03-2020 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.

Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe Product Label Images

Simpleaf Advanced Hand Sanitizer Moisturizer And Vitamin E And Aloe 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(s)                                PurposeAlcohol  71%       ...............                 Antiseptic

Otc - Purpose

  • Hand sanitizer to help decrease bacteria on the skin.When water, soap and towel are not available.Recommendd for repeated use.

Otc - Keep Out Of Reach Of Children

Children must be supervised in use of this product.

Indications & Usage

  • Wet hands thoroughly with product and allow to dry without wipingadult supervision required for children under 6Not recommended for infants.

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 product, avoid contact with eyes. In case of contact, flush eyes with water.Stop using, consult doctor if redness or irritation develop and persist for more than 72 hours.

Dosage & Administration

  • Other information:Do not Store above 105℉might be harmful to wood and plastic

Inactive Ingredient

Water, Triethanolamine, Glycerin, Propylene glycol, Aloe Barbadensis gel, carbomer, vitamin E

* Please review the disclaimer below.