NDC 71734-311 Bactro Instant Hand Sanitizer

Alcohol

NDC Product Code 71734-311

NDC 71734-311-01

Package Description: 2 mL in 1 DOSE PACK

NDC Product Information

Bactro Instant Hand Sanitizer with NDC 71734-311 is a a human over the counter drug product labeled by Jiangmen Shuizirun Sanitary Articles Co., Ltd.. The generic name of Bactro Instant Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Jiangmen Shuizirun Sanitary Articles Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Bactro Instant Hand Sanitizer 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 75 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

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: Jiangmen Shuizirun Sanitary Articles Co., Ltd.
Labeler Code: 71734
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: 07-10-2020 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.

Bactro Instant Hand Sanitizer Product Label Images

Bactro Instant Hand Sanitizer 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

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

  • Apply topically as needed to cleanse

Warnings

  • For external use only.Flammable, keep from fire or flame.Avoid contact with broken skin.When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rah appears and lasts.Other informationDo not store above 110℉May discolor some fabrics.

Keep Out Of Reach Of Children.

If swallowed, get medical help.

Directions

  • Wet hands thoroughly with product and allow to dry without wiping.Children under 6 years of age should be supervised when using this product.Not recomended for infants.

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30Alkyl Acrylate Crosspolymer, Ainomethyl Propanol, Fragrance (Parfum), Denatonium Benzoate, Tocopheryl Actate, Aloe Barbadensis Leaf Juice, Maltodextrin.

* Please review the disclaimer below.