NDC 71884-011 My-shield Hand Sanitizer Gel

Benzalkonium Chloride

NDC Product Code 71884-011

NDC 71884-011-01

Package Description: 3 TUBE in 1 PACKAGE > 30 mL in 1 TUBE

NDC 71884-011-02

Package Description: 59 mL in 1 BOTTLE

NDC 71884-011-04

Package Description: 118 mL in 1 BOTTLE

NDC 71884-011-06

Package Description: 177 mL in 1 BOTTLE

NDC 71884-011-08

Package Description: 244 mL in 1 BOTTLE

NDC Product Information

My-shield Hand Sanitizer Gel with NDC 71884-011 is a a human over the counter drug product labeled by Enviro Specialty Chemicals Inc. The generic name of My-shield Hand Sanitizer Gel is benzalkonium chloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Enviro Specialty Chemicals Inc

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.

My-shield Hand Sanitizer Gel 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.

  • BENZALKONIUM CHLORIDE .13 g/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)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • POLIHEXANIDE (UNII: 322U039GMF)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

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: Enviro Specialty Chemicals Inc
Labeler Code: 71884
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: 05-26-2020 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’.

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My-shield Hand Sanitizer Gel Product Label Images

My-shield Hand Sanitizer Gel 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:

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic/Hand & Skin Sanitizer

Uses:

Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use.

Warnings:

Do not freeze. For external use only.Do not use in ears, eyes or mouth.• When using this product, avoid contact with the eyes. In case of contact, flush eyes with water.• Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours.• Children should be supervised when using this product.

Otc - Keep Out Of Reach Of Children

• Keep out of reach of children.

Directions:

Apply liberally to the palms of the hands. Rub into skin until dry. Recommended for repeat use

Inactive Ingredients:

Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Hydroxyethyl Cellulose,Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

Questions?

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