NDC 73065-0006 Herba Purgo Hands Sanitizer Gel(ethanol)

Alcohol

NDC Product Code 73065-0006

NDC 73065-0006-1

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Herba Purgo Hands Sanitizer Gel(ethanol) with NDC 73065-0006 is a a human over the counter drug product labeled by Woorilife&health. The generic name of Herba Purgo Hands Sanitizer Gel(ethanol) is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Woorilife&health

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.

Herba Purgo Hands Sanitizer Gel(ethanol) 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 350 mL/500mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CITRUS X LIMON FRUIT OIL (UNII: 0HNC1J1YED)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Woorilife&health
Labeler Code: 73065
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: 09-02-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Herba Purgo Hands Sanitizer Gel(ethanol) Product Label Images

Herba Purgo Hands Sanitizer Gel(ethanol) 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

Otc - Active Ingredient

Alcohol

Inactive Ingredient

Glycerim, triethanolamine, carbomer, aloe barbadensis leaf extract, propylene glycol, citrus limon (lemon) fruit oil, green tea extract, hinoki oil, sage extract, calendula extract, water

Otc - Purpose

Antiseptic

Otc - Keep Out Of Reach Of Children

Take moderate amount on hands and rub well to dry

Indications & Usage

  • Adults and children 2 years of age and olderBrush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or docter.Children under 6 yearsTo minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.Children under 2 years Consult a dentist or doctor

Warnings

1) Be careful not to swallow it, and rinse your mouth thoroughly after use.2) If any abnormalities such as gum or mouth damage are caused by using this toothpaste, stop using the product and consult a doctor or dentist.3) For children under 6 years of age, use a small amount of pea toothpaste per serving and use it under the supervision of a guardian to avoid sucking or swallowing.4) If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.5) Keep out of reach of children under 6 years old.

Dosage & Administration

For external use only

* Please review the disclaimer below.