NDC 78063-030 Sanotis Sanitizer Hand

Alcohol

NDC Product Code 78063-030

NDC 78063-030-01

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC Product Information

Sanotis Sanitizer Hand with NDC 78063-030 is a a human over the counter drug product labeled by Megacos Manufacturing Co., Ltd.. The generic name of Sanotis Sanitizer Hand is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Megacos Manufacturing 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.

Sanotis Sanitizer Hand 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 210 g/300mL

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)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • 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.
  • 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: Megacos Manufacturing Co., Ltd.
Labeler Code: 78063
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: 06-01-2020 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.

Sanotis Sanitizer Hand Product Label Images

Sanotis Sanitizer Hand 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 70% w/w

Inactive Ingredient

Water, Allantoin, Panthenol, Glycerin, Carbomer, Aminomethyl Propanol

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame--------------------------------------------------------------------------------------------------------Do not use• in children less than 2 months of age• on open skin wounds--------------------------------------------------------------------------------------------------------When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.----------------------------------------------------------------------- ---------------------------------Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Sanotis sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.

Directions

• Place enough product on hands to cover all surface. Rub hands together until dry.• Supervise children under 6 years of age when using this product to avoid swallowing.• Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)• This product is intended only for sanitizing.• To prevent contents from drying out and contaminants from entering, close lid completely after use.• Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.• Do not use over bandage, castings, etc. as irritation occur.

Other Information

• Store between 1-30℃ (33.8-86℉)• Avoid freezing and excessive heat above 40℃ (104℉)

* Please review the disclaimer below.