NDC 68306-114 Avant Eco-premium Instant Hand Sanitizer

Alcohol

NDC Product Code 68306-114

NDC 68306-114-01

Package Description: 118 mL in 1 BOTTLE, DISPENSING

NDC 68306-114-02

Package Description: 251 mL in 1 BOTTLE, PUMP

NDC 68306-114-03

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC 68306-114-04

Package Description: 1890 mL in 1 BOTTLE, PUMP

NDC 68306-114-05

Package Description: 1000 mL in 1 POUCH

NDC 68306-114-06

Package Description: 1000 mL in 1 BOTTLE, DISPENSING

NDC 68306-114-07

Package Description: 3785 mL in 1 JUG

NDC Product Information

Avant Eco-premium Instant Hand Sanitizer with NDC 68306-114 is a a human over the counter drug product labeled by B4 Ventures Llc. The generic name of Avant Eco-premium Instant Hand Sanitizer is alcohol. 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: 582753.

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.

Avant Eco-premium Instant 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.


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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

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: B4 Ventures Llc
Labeler Code: 68306
FDA Application Number: part333E 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: 05-01-2012 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.

Avant Eco-premium Instant Hand Sanitizer Product Label Images

Avant Eco-premium Instant 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

Other

USDA Certified BioBased Product - Product 98%Certified EcoLogo - Certified Instant Hand Antiseptic CCD-170Enriched with natural moisturizers: glycerin, aloe and panthenol (Pro Vitamin B5)Fragrance-free and dye-freeNon-irritating and allergy-testedwww.b4brands.com

Active Ingredient

Ethanol 70%

Purpose

Antimicrobial

Warnings

For External use only.Flammable, keep away from fire or flame.When using this product do not use in or near eyes. In case of eye contact, flush thoroughly with water.

Otc - Stop Use

Stop use and ask doctor if irritation and redness develop 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 a Poison Control Center right away.

Other Information

  • Do not store above 100F (38C)May discolor some fabrics

Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Accrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol

Directions

  • Dispense an adequate amount in your palm to cover all surfaces of hands completelyRub hands together until drySupervise children in the use of this product

Uses

  • Hand sanitizer to help reduce bacteria on the skinRecommended for repeated use

* Please review the disclaimer below.