NDC 77049-0007 Mudsoo Bacteria Zero Handcream

Alcohol

NDC Product Code 77049-0007

NDC 77049-0007-1

Package Description: 60 mL in 1 TUBE

NDC Product Information

Mudsoo Bacteria Zero Handcream with NDC 77049-0007 is a a human over the counter drug product labeled by Interkos Co., Ltd.. The generic name of Mudsoo Bacteria Zero Handcream is alcohol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Interkos Co., Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Mudsoo Bacteria Zero Handcream 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.

  • BENZALKONIUM CHLORIDE .05 g/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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • 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: Interkos Co., Ltd.
Labeler Code: 77049
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: 10-23-2020 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.

Mudsoo Bacteria Zero Handcream Product Label Images

Mudsoo Bacteria Zero Handcream 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

Benzalkonium Chloride

Inactive Ingredient

Water

Glycerin

Sodium Polyacrylate

Styrene/VP Copolymer

Butylene Glycol

Triethyl Citrate

PEG-60 Hydrogenated Castor Oil

1,2-Hexanediol

Caprylyl Glycol

Cetyl Ethylhexanoate

Salvia Officinalis (Sage) Oil

Trideceth-10

PEG-14M

Illicium Verum (Anise) Fruit Extract

Salix Alba (Willow) Bark Extract

Chamaecyparis Obtusa Leaf Extract

Origanum Vulgare Leaf Extract

Lactobacillus/Soybean Ferment Extract

Scutellaria Baicalensis Root Extract

Portulaca Oleracea Extract

Cinnamomum Cassia Bark Extract

Aloe Barbadensis Leaf Extract

Otc - Purpose

Protecting hands from the harmful environment and keeping hands healthy and clean with anti-germ effects, providing moist hands by nutrition and moisturizing.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

1. In case of having side effects such as red rash,

swollenness or itching while using this cosmetic, or in case

such symptoms appear by direct snulight after using it,

consult a dermatologist immediately.

2. Do not apply on skin where there is wound, eczema, or irritation.

3. Storage and cautions for handling.

A. keep out of reach of children.

B. keep away from direct sunlight.

Warnings

1. Do not use for other purposes than its usage.2. keep away from direct sunlight or heat.3. Do not direct to people or food. .4. Do not forcibly open the cap combined to the container.5. When the content is frozen, use it on an ordinary temperature for preventing change inquality. .6. If eyes or skins are exposed to the contents, washing the area with the running waterand when the abnormal symptoms occur, consult doctors.7. Be careful when the containers are brought down and the contents may flow out.8. Directing on the higher area than eyes, the contents may be exposed to eyes and applythe contents on the sponges or the fabrics.9. Ventilation is required in sealed areas.10. When discoloring and bleaching happen on some areas for applying, please check theirpossibility in advance.11. After using the products, do not change the containers.12. If the contents are swallowed, take emergency process and consult with doctors.13. keep out of reach of children.

Dosage & Administration

For external use only

* Please review the disclaimer below.