NDC 62651-062 Hand Sanitizer Pen Sweet Pomegranate

Alcohol

NDC Product Code 62651-062

NDC 62651-062-01

Package Description: 8 mL in 1 BOTTLE, SPRAY

NDC Product Information

Hand Sanitizer Pen Sweet Pomegranate with NDC 62651-062 is a a human over the counter drug product labeled by Base4 Ventures, Inc. The generic name of Hand Sanitizer Pen Sweet Pomegranate is alcohol. The product's dosage form is gel and is administered via topical form.

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.

Hand Sanitizer Pen Sweet Pomegranate 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)

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: Base4 Ventures, Inc
Labeler Code: 62651
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: 09-15-2021 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.

Hand Sanitizer Pen Sweet Pomegranate Product Label Images

Hand Sanitizer Pen Sweet Pomegranate 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

Alcohol Denat. 70%

Purpose

Antimicrobial

Use

  • To decrease bacteria on the skin.

Warnings

  • For external use only.Flammable, keep away from heat and flameDoes not contain grain alcohol; do not drink. If taken internally will produce serious gastric disturbances

When Using This Product

  • Avoid the eyes and mucous membranesIn the case of eyes or mucous membrane contact, rinse thoroughly with water

Stop Use And Ask A Doctor If

  • Condition worsensRedness or irritation developsIf condition persists for more than 3 days

Keep Out Of Reach Of Children.

If swallowed contact a doctor or Poison Control Center immediately.

Directions

  • Rub dime sized amount between hands until dry Supervise children in the use of this product In the case of eye contact rinse eyes thoroughly with water

Other Information

  • Store below 105ºFMay discolor some fabrics

Inactive Ingredients:

Water, Glycerin, F
ragrance, Disodium EDTA.

Questions?

Call 1-888-988-2427

* Please review the disclaimer below.