NDC 73401-975 Sopuro Antibacterial Hand Cleaner Fragrance Free


NDC Product Code 73401-975

NDC 73401-975-01

Package Description: 500 mL in 1 BOTTLE

NDC 73401-975-02

Package Description: 1000 mL in 1 BOTTLE

NDC Product Information

Sopuro Antibacterial Hand Cleaner Fragrance Free with NDC 73401-975 is a a human over the counter drug product labeled by Previcare Pharmaceutical, Inc.. The generic name of Sopuro Antibacterial Hand Cleaner Fragrance Free is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Previcare Pharmaceutical, Inc.

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.

Sopuro Antibacterial Hand Cleaner Fragrance Free 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 70 mL/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.

  • WATER (UNII: 059QF0KO0R)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)

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: Previcare Pharmaceutical, Inc.
Labeler Code: 73401
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: 11-01-2020 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.

Sopuro Antibacterial Hand Cleaner Fragrance Free Product Label Images

Sopuro Antibacterial Hand Cleaner Fragrance Free 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


Drug Facts

Distributed by: Previcare Pharmaceutical, Inc.50 Fountain Plaza, Suite 1400Buffalo, NY 14202

Active Ingredient

Ethanol (Ethyl Alcohol) 70% V/V




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


For external use only. Flammable.Do not ingest. Keep away from heat or flame.

Do Not Use

  • If you are allergic to any ingredient.On open wounds.

When Using This Product

Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help.


  • Apply to one palm, rub hands together until dry.Use as part of your daily cleaning routine.Do not rinse with water, do not dilute the product.Supervise children when using this product.

Other Information

Store at 15-30°C (59-86°F).Avoid freezing and excessive heat above 40°C (104°F).

Inactive Ingredients

Aqua, glycerin, aloe barbadensis (Aloe) leaf juice, PEG-75 lanolin, myristyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine.

* Please review the disclaimer below.