NDC 78396-002 Hand Sanitizer

Ethyl Alcohol

NDC Product Code 78396-002

NDC 78396-002-01

Package Description: 59 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 78396-002 is a a human over the counter drug product labeled by B Holding Group Llc. The generic name of Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: B Holding Group 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.

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 62 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.

  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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 Holding Group Llc
Labeler Code: 78396
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: 05-29-2020 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.

Hand Sanitizer Product Label Images

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

Otc - Active Ingredient

Active Ingredient

Ethyl Alcohol 62%

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

UsesFor hand washing to decrease bacteria on the skin.Recommended for repeated use.

Warnings

WarningsFor external use only.Flammable. Keep away from fire or flame.

Otc - When Using

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash develops, or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

DirectionsNot recommended for infants.Wet hands thoroughly with product and allow to dry without wiping.Children under 6 years of age should be supervised when using this product.

Storage And Handling

Other InformationStore below 110°F. May cause discoloration to some fabrics or surfaces.

Inactive Ingredient

Inactive IngredientsWater, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

* Please review the disclaimer below.