NDC 54748-301 Everyone Hand Sanitizer Coconut Lemon

Alcohol

NDC Product Code 54748-301

NDC 54748-301-05

Package Description: 59 mL in 1 BOTTLE

NDC 54748-301-07

Package Description: 946 mL in 1 BOTTLE

NDC 54748-301-08

Package Description: 237 mL in 1 BOTTLE

NDC 54748-301-09

Package Description: 6 BOTTLE in 1 PACKAGE > 59 mL in 1 BOTTLE (54748-301-05)

NDC 54748-301-12

Package Description: 946 mL in 1 BOTTLE

NDC Product Information

Everyone Hand Sanitizer Coconut Lemon with NDC 54748-301 is a a human over the counter drug product labeled by Eo Products, Llc. The generic name of Everyone Hand Sanitizer Coconut Lemon is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Eo Products, Llc

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.

Everyone Hand Sanitizer Coconut Lemon 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/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)
  • LEMON OIL (UNII: I9GRO824LL)
  • .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
  • .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
  • PIPERONAL (UNII: KE109YAK00)
  • VANILLIN (UNII: CHI530446X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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: Eo Products, Llc
Labeler Code: 54748
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: 06-07-2013 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.

Everyone Hand Sanitizer Coconut Lemon Product Label Images

Everyone Hand Sanitizer Coconut Lemon 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:

Ethanol 62%

Purpose:

Antiseptic

Uses:

  • For hand washing to decrease bacteria on skinRecommended for repeated use

Warnings:

  • Flammable, keep away from fire/flameFor external use onlyDo not use in eyes. If contact occurs, flush thoroughly with water.Stop use and contact a doctor if redness and irritation develops and 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 the Poison Control center right away.

Directions:

  • Wet hands thoroughly with product and allow to dry without wipingDo not use other than directed.

Inactive Ingredients:

Purified Water, Citrus Medica Limonum (Lemon) Peel Oil, Organic Cocos Nucifera (Coconut) Flavor Extract, Vegetable Glycerin.

Other Information:

  • Store at room temperature 200-250C (660F - 770F)May discolour certain fabrics.

Other

99.9% EFFECTIVE against most common germsno gmos / no synthetic fragrances / no triclosanmade with plant extracts + pure essential oilsEO Everyone, ® Marin County, CA 94901Made in the USA From Domestic and Globally Sourced Ingredients800-570-3775 www.eoproducts.com

* Please review the disclaimer below.