NDC 68062-2293 Primal Elements Antibacterial

Benzalkonium Chloride

NDC Product Code 68062-2293

NDC 68062-2293-1

Package Description: 227 mg in 1 BOTTLE

NDC Product Information

Primal Elements Antibacterial with NDC 68062-2293 is a a human over the counter drug product labeled by Spa De Soleil. The generic name of Primal Elements Antibacterial is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Spa De Soleil

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Primal Elements Antibacterial 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 .295 mg/227mg

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)

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: Spa De Soleil
Labeler Code: 68062
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: 10-01-2020 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.

Primal Elements Antibacterial Product Label Images

Primal Elements Antibacterial 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

Warnings

WarningsFor external use only. If product gets in eyes, rinse promptly and thoroughly with water. Discontinue use if irritation and redness occur.Stop use and ask a doctor if irritation or redness lasts for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together until dry.

Dosage & Administration

Place enough product in the palm of your hands to thoroughly cover you hands. Rub hands together briskly until product is completely absorbed and hands are dry.Inactive Ingredients:

Inactive Ingredients

Inactive Ingredients:Aqua, Isononyl Isononanoate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Palmitoyl Tripeptide-5, Glycerin, *CO Glycerin, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified Organic

* Please review the disclaimer below.