NDC 55418-001 Venusamy Clean Gel

Venusamy Clean Gel

NDC Product Code 55418-001

NDC 55418-001-01

Package Description: 70 mL in 1 BOTTLE

NDC Product Information

Venusamy Clean Gel with NDC 55418-001 is a a human over the counter drug product labeled by Elink Technology Co., Ltd.. The generic name of Venusamy Clean Gel is venusamy clean gel. The product's dosage form is gel and is administered via extracorporeal form.

Labeler Name: Elink Technology Co., Ltd.

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.

Venusamy Clean 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.

  • ALCOHOL 49 mL/70mL

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.

  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • PURSLANE (UNII: M6S840WXG5)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
  • MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Extracorporeal - Administration outside of the body.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Elink Technology Co., Ltd.
Labeler Code: 55418
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: 04-23-2020 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.

Venusamy Clean Gel Product Label Images

Venusamy Clean 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

Dosage & Administration

Keep away from fire or flame. Store conventionallyin a cool,dry place, out of direct sunlight.

Inactive Ingredient

WaterCarbomerGlycerinTriethanolaminePEG-60 Hydrogenated Castor OilPEG-40 Hydrogenated Castor OilHydroxyethylcelluloseMentha Arvensis Leaf OilScutellaria Baicalensis Root ExtractPortulaca Oleracea ExtractAloe Barbadensis Leaf Extract

Indications & Usage

Apply proper amount of Venusamy Clean Gel to your palm then briskly rub hands together evenly until completely dry.

Otc - Active Ingredient

Alcohol

Otc - Keep Out Of Reach Of Children

Keep out of children

Otc - Purpose

Disinfection

Sterilization

No Rinseing

Warnings

For etemal use only. Discontinue use immediatelyif the fllowing conditionsoccurs and consult a doctor. Some imitaton, redness, rash or

stinging stimulation may occur ater use it Direct UV may occur conditlons above. Avoid wounds,eczema or dermatitis.

* Please review the disclaimer below.