NDC 50663-342 Dial Complete Advanced Moisture Spring Water

Dial Complete Advanced Moisture Spring Water Fhw

NDC Product Code 50663-342

NDC CODE: 50663-342

Proprietary Name: Dial Complete Advanced Moisture Spring Water 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: Dial Complete Advanced Moisture Spring Water Fhw 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

NDC 50663-342-01

Package Description: 1180 mL in 1 BOTTLE, PUMP

NDC 50663-342-02

Package Description: 3780 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Dial Complete Advanced Moisture Spring Water with NDC 50663-342 is a a human over the counter drug product labeled by Zotos International Inc. The generic name of Dial Complete Advanced Moisture Spring Water is dial complete advanced moisture spring water fhw. The product's dosage form is solution and is administered via topical form.

Labeler Name: Zotos International Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Dial Complete Advanced Moisture Spring Water 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.

  • 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: Zotos International Inc
Labeler Code: 50663
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: 11-01-2020 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.

Dial Complete Advanced Moisture Spring Water 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

Antibacterial

Uses

For Handwashing to decreases bacteria on the skin.

Warnings

For external use only.

When Using This Product

Avoid Contact with eyes. In case of eye contact, flush with water.

Stop Use And Ask Doctor If

Irritation or redness develops

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Pump into DRY hands.Later vigorously for at least 20 seconds.Rinse and dry thoroughly.

Inactive Ingredients

Advanced Moisture Spring Water FHWAqua (Water, Eau) · Lauramidopropylamine Oxide · Cetrimonium Chloride · Glycerin · Lauramine Oxide · Citric Acid · Cocamidopropyl Betaine · Trideceth-9 · Sodium Benzoate · Myristamidopropylamine Oxide · PEG-5 Isononanoate · Parfum (Fragrance) · Zinc Sulfate · Sodium Chloride · Dimethyl Lauramine · Tetrasodium EDTA · Alcohol · Dimethyl Myristamine · CI 42090 (Blue 1) · CI 17200 (Red 33)

Questions

Www.dialsoap.comcall 1-800-258-DIAL(3425)

®,TM,©2020Distributed by HenkelCorporation, Rocky Hill, CT 06067

*Encountered In Household Settings

REFILL ONLY WITH DIAL COMPLETE FOAMING HAND WASH

Indications & Usage

For handwashing to decrease bacteria on the skin.

Topical Liquid Solution

Foaming Hand wash

4 Pack

10 FL OZ (296mL) EACHTOTAL 40 FL OZ (1.18 L)

* Please review the disclaimer below.