NDC 78434-100 Accurate Labs Antiseptic Hand Sanitizer
Ethyl Alcohol Gel Topical

Product Information

What is NDC 78434-100?

The NDC code 78434-100 is assigned by the FDA to the product Accurate Labs Antiseptic Hand Sanitizer which is a human over the counter drug product labeled by Accurate Labs, Llc. The generic name of Accurate Labs Antiseptic Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form. The product is distributed in 11 packages with assigned NDC codes 78434-100-02 .059 l in 1 bottle, pump , 78434-100-04 .118 l in 1 bottle, pump , 78434-100-08 .236 l in 1 bottle, pump , 78434-100-16 .473 l in 1 bottle, pump , 78434-100-32 .946 l in 1 bottle, pump , 78434-100-64 1.89 l in 1 container , 78434-100-70 3.79 l in 1 container , 78434-100-75 9.46 l in 1 container , 78434-100-80 18.93 l in 1 container , 78434-100-85 208.2 l in 1 container , 78434-100-90 1211.33 l in 1 container . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code78434-100
Proprietary Name 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.
Accurate Labs Antiseptic Hand Sanitizer
Non-Proprietary Name 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.
Ethyl Alcohol
Product Type 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.
Human Otc Drug
Dosage FormGel - 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.
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.
Accurate Labs, Llc
Labeler Code78434
FDA Application Number 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.
part333A
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-01-2020
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
06-30-2025
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Accurate Labs Antiseptic Hand Sanitizer?


Product Packages

NDC Code 78434-100-02

Package Description: .059 L in 1 BOTTLE, PUMP

NDC Code 78434-100-04

Package Description: .118 L in 1 BOTTLE, PUMP

NDC Code 78434-100-08

Package Description: .236 L in 1 BOTTLE, PUMP

NDC Code 78434-100-16

Package Description: .473 L in 1 BOTTLE, PUMP

NDC Code 78434-100-32

Package Description: .946 L in 1 BOTTLE, PUMP

NDC Code 78434-100-64

Package Description: 1.89 L in 1 CONTAINER

NDC Code 78434-100-70

Package Description: 3.79 L in 1 CONTAINER

NDC Code 78434-100-75

Package Description: 9.46 L in 1 CONTAINER

NDC Code 78434-100-80

Package Description: 18.93 L in 1 CONTAINER

NDC Code 78434-100-85

Package Description: 208.2 L in 1 CONTAINER

NDC Code 78434-100-90

Package Description: 1211.33 L in 1 CONTAINER

Product Details

What are Accurate Labs Antiseptic Hand Sanitizer Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Accurate Labs Antiseptic Hand Sanitizer Active Ingredients UNII Codes

Accurate Labs Antiseptic Hand Sanitizer Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Accurate Labs Antiseptic Hand Sanitizer Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Ethyl alcohol 80% v/v


Purpose



Antiseptic


Uses



• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available


Warnings



Flammable, keep away from fire/flame
For external use only

Do not use • in children less than 2 months of age • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product to avoid swallowing

Other Information



• store between 20-25˚C (68-77˚F)
• avoid freezing and excessive heat above 40˚C (104˚F)
• may discolor certain fabrics


Inactive Ingredients



Carbopol Aqua SF-1, d-limonene, glycerin,triethanolamine, water


Questions?



1-800-484-1699
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM


Other



Alcohol Antiseptic 80%

Topical Solution

Non-Sterile Solution

Manufactured for: Accurate Labs, LLC
301W 50th St, Odessa, TX 79764


* Please review the disclaimer below.