NDC 69580-170 Deep Steep Fragrance Free Hand Sanitizer

Deep Steep Fragrance Free Hand Sanitizer Spray

NDC Product Code 69580-170

NDC CODE: 69580-170

Proprietary Name: Deep Steep Fragrance Free Hand Sanitizer 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: Deep Steep Fragrance Free Hand Sanitizer Spray 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 69580-170-04

Package Description: 60 mL in 1 BOTTLE

NDC 69580-170-05

Package Description: 120 mL in 1 BOTTLE

NDC 69580-170-06

Package Description: 520 mL in 1 BOTTLE

NDC Product Information

Deep Steep Fragrance Free Hand Sanitizer with NDC 69580-170 is a a human over the counter drug product labeled by Royal Labs Natural Cosmetics, Inc.. The generic name of Deep Steep Fragrance Free Hand Sanitizer is deep steep fragrance free hand sanitizer spray. The product's dosage form is spray and is administered via topical form.

Labeler Name: Royal Labs Natural Cosmetics, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Deep Steep Fragrance Free Hand Sanitizer 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 62 mL/62mL

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Royal Labs Natural Cosmetics, Inc.
Labeler Code: 69580
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: 09-22-2020 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.

Deep Steep Fragrance Free Hand Sanitizer Product Label Images

Deep Steep Fragrance Free Hand Sanitizer 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

Inactive Ingredient Section

Inactive Ingredients: Aqua, Glyercin, Organic Aloe Barbadensis Leaf Juice

Dosage & Administration Section

62% Alcohol

Indications & Usage Section

Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Otc- Keep Out Of Reach Of Children

Keep out of reach of children.

Otc-Purpose Section

Uses: For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Otc-Active Ingredient Section

Ethyl Alcohol 62% Antiseptic

Warnings Section

For external use only. Flammable, keep away from fire or flame.

Deep Steep Fragrance Free Hand Sanitizer Spray 62%

Deep Steep Fragrance Free Hand Sanitizer Spray 62%

* Please review the disclaimer below.