NDC 69343-421 Elyptol Light Scent- Antimicrobial Hand Gel

Ethanol

NDC Product Code 69343-421

NDC 69343-421-01

Package Description: 1 PACKET in 1 CARTON > 2 mL in 1 PACKET

NDC 69343-421-02

Package Description: 1 BOTTLE in 1 CARTON > 59 mL in 1 BOTTLE

NDC 69343-421-08

Package Description: 1 BOTTLE in 1 CARTON > 236 mL in 1 BOTTLE

NDC 69343-421-15

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

NDC 69343-421-16

Package Description: 1 BOTTLE in 1 CARTON > 473 mL in 1 BOTTLE

NDC 69343-421-32

Package Description: 1 BOTTLE in 1 CARTON > 946 mL in 1 BOTTLE

NDC 69343-421-42

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 1242 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Elyptol Light Scent- Antimicrobial Hand Gel with NDC 69343-421 is a a human over the counter drug product labeled by Elyptol Inc.. The generic name of Elyptol Light Scent- Antimicrobial Hand Gel is ethanol. 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: 581662.

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.

Elyptol Light Scent- Antimicrobial Hand Gel 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)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
  • PIROCTONE OLAMINE (UNII: A4V5C6R9FB)

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: Elyptol Inc.
Labeler Code: 69343
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: 06-01-2016 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 - 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.

Elyptol Light Scent- Antimicrobial Hand Gel 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:

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Keep Out Reach Of Children

If swallowed, seek medical advice or contact a Poison Control Center immediately.

Uses

  • To decrease bacteria on skin.Recommended for repeated use.

Warnings

For external use onlyFlammable. Keep away from sources of fire or flame.When using this productkeep away from eyes. In case of eye contact, rinse eyes with water.


Stop use and ask a doctor ifredness or irritation develops. If issues persist, seek medical attention.

Directions

  • Apply Elyptol liberally onto palm of hand.Cover hands with product by thoroughly rubbing and allow to air dry without wipingUse undilutedSupervise children under 6 yearsNot recommended for infants

Other Information

  • Store below 86°F/30°CKeep out of direct sunlight.

Inactive Ingredients

Aqua (Purified Water), Eucalyptol, Glycerin, Hydroxypropylcellulose, Piroctone Olamine.

Otc - Questions

Questions?(888) 424-9874

Other

Moisturizing Hand SanitizerNATURAL INGREDIENTSSUITABLE FOR HIGH FREQUENCY USEKILLS


99.99% of GERMS


NO NEED TO RINSEDermatologically TestedNot Tested On Animals

* Please review the disclaimer below.