NDC 75512-042 Hsc70
Ethanol
NDC Product Code 75512-042
Proprietary Name: Hsc70 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Ethanol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NDC Code Structure
- 75512 - Integrity Bio-chemicals, Llc
- 75512-042 - Hsc70
NDC 75512-042-01
Package Description: 3.79 L in 1 BOTTLE, PLASTIC
NDC 75512-042-05
Package Description: 1230.26 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
NDC 75512-042-09
Package Description: .5 L in 1 BOTTLE, PLASTIC
NDC Product Information
Hsc70 with NDC 75512-042 is a a human over the counter drug product labeled by Integrity Bio-chemicals, Llc. The generic name of Hsc70 is ethanol. The product's dosage form is gel and is administered via topical form.
Labeler Name: Integrity Bio-chemicals, Llc
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.
Hsc70 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)
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
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: Integrity Bio-chemicals, Llc
Labeler Code: 75512
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: 12-14-2020 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: 12-31-2022 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 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.
Hsc70 Product Label Images
Hsc70 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
- Other
- Otc - Active Ingredient
- Otc - Purpose
- Indications & Usage
- Warnings
- Otc - Do Not Use
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Dosage & Administration
- Other Safety Information
- Inactive Ingredient
- Package Label
Other
Drug Facts
Otc - Active Ingredient
Active Ingredien(s) Ethyl Alcohol 70% v/v
Otc - Purpose
Purpose Antiseptic
Indications & Usage
UsesHand sanitizer to help reduce bacteria that potentially can cause decrease. For usewhen soap and water are not available.
Warnings
WarningsFor external use only. Flammable. Keep away from heat or flame
Otc - Do Not Use
Do not use• On children less than 2 months of age• On open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs. They may be signs ofa serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center right away.
Dosage & Administration
Directions• Place enough product on hands to cover all surfaces. Rub hands together until dry.• Supervise children under 6 years of age when using the product to avoid swallowing.
Other Safety Information
Other information• Store between 15-30C (59-86F)• Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Inactive Ingredients Carbomer, Glycerin, Water
Package Label
Clean LyfeHAND SANITIZERUNSCENTEDMOISTURIZING GEL1 US Gallon (3.79 L) • 70% AlcohoLManufactured by:Integrity BioChemCresson, TX, 76035integritybiochem.com1 GAL 325 Gal500 mLres
* Please review the disclaimer below.