NDC 78174-045 Hygieni-klean Hand Sanitizer Gel Healthcare Grade


NDC Product Code 78174-045

NDC 78174-045-01

Package Description: 3.78541 L in 1 JUG

NDC 78174-045-02

Package Description: .946353 L in 1 BOTTLE

NDC 78174-045-03

Package Description: .473176 L in 1 BOTTLE

NDC 78174-045-04

Package Description: .354882 L in 1 BOTTLE

NDC 78174-045-05

Package Description: .236588 L in 1 BOTTLE

NDC 78174-045-06

Package Description: .118294 L in 1 BOTTLE

NDC 78174-045-07

Package Description: .0591471 L in 1 BOTTLE

NDC Product Information

Hygieni-klean Hand Sanitizer Gel Healthcare Grade with NDC 78174-045 is a a human over the counter drug product labeled by Custom Chemical Services, Llc. The generic name of Hygieni-klean Hand Sanitizer Gel Healthcare Grade is ipa. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2397699.

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.

Hygieni-klean Hand Sanitizer Gel Healthcare Grade 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.

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Custom Chemical Services, Llc
Labeler Code: 78174
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: 01-09-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hygieni-klean Hand Sanitizer Gel Healthcare Grade Product Label Images

Hygieni-klean Hand Sanitizer Gel Healthcare Grade 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 Ingredients

Isopropanol 80% v/v



Indications & Usage

Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.


Warning Flammable. Keep away from fire or flame. For external use only.

Otc - When Using

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

Storage And Handling

Other Information Store under 105°F.

Dosage & Administration

Directions Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Inactive Ingredient

Inactive Ingredients Purified water, Glycerin USP, PEG-600, Carbomer

* Please review the disclaimer below.