NDC 90120-000 B Free Hand Sanitizer With Aloe Vera And Vitamin E

Alcohol

NDC Product Code 90120-000

NDC 90120-000-01

Package Description: 100 mL in 1 BOTTLE

NDC 90120-000-02

Package Description: 500 mL in 1 BOTTLE

NDC 90120-000-03

Package Description: 3790 mL in 1 BOTTLE

NDC Product Information

B Free Hand Sanitizer With Aloe Vera And Vitamin E with NDC 90120-000 is a a human over the counter drug product labeled by B+free. The generic name of B Free Hand Sanitizer With Aloe Vera And Vitamin E is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: B+free

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.

B Free Hand Sanitizer With Aloe Vera And Vitamin E 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 .7 mL/mL

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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: B+free
Labeler Code: 90120
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: 09-01-2020 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.

B Free Hand Sanitizer With Aloe Vera And Vitamin E Product Label Images

B Free Hand Sanitizer With Aloe Vera And Vitamin E 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 70%

Purpose

Antiseptic

Uses

  • Hand sanitizer to decrease bacteria on the skin.recommended for repeated usefor use when soap and water are not available.

Warnings

Flammable, keep away from fire/flame. For external use only

Do Not Use

  • On children less than 2 months of ageon open skin wounds.

When Using This Product

  • Do not get into eyes. In case of contact, rinse eyes thoroughly with waterdo not inhale or ingest.

Stop Use And Ask A Doctor If

  • Irritation and redness developcondition persista for more than 72 hours

Keep Out Of Reach Of Children.

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping.supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 59-86ºF (15-30ºC)avoid freezing and excessive heat above 104ºF. (40ºC)may discolor certain fabrics or surfaces

Inactive Ingredients

Aqua, Glycerin, Parfum, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, PEG-40 Hydrogenated Castor Oil, Tocopheryl Acetate(Vitamin E), Aloe Barbadensis Leaf Extract (Aloe Vera).

* Please review the disclaimer below.