NDC 79515-000 Biosilk Hand Sanitizer

Biosilk Hand Sanitizer

NDC Product Code 79515-000

NDC 79515-000-12

Package Description: 355 g in 1 BOTTLE, PLASTIC

NDC 79515-000-25

Package Description: 739 g in 1 BOTTLE, PUMP

NDC 79515-000-99

Package Description: 3785 g in 1 BOTTLE, PLASTIC

NDC Product Information

Biosilk Hand Sanitizer with NDC 79515-000 is a a human over the counter drug product labeled by Hirsch Gift, Inc. The generic name of Biosilk Hand Sanitizer is biosilk hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Hirsch Gift, 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.

Biosilk 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 77 g/100g

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.

  • CITRAL (UNII: T7EU0O9VPP)
  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • WATER (UNII: 059QF0KO0R)
  • FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Hirsch Gift, Inc
Labeler Code: 79515
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: 07-15-2020 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.

Biosilk 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

Dosage & Administration

Active ingredient Purpose

Ethyl Alcohol 77% v/v Antimicrobial
Use for hand-washing to decrease bacteria on

the skin, only when water is not available.

Inactive Ingredients

Inactive ingredients

Aloe Barbadensis Leaf

Extract*, Aqua/Water/Eau,

Glycerin, Propanediol,

Acrylates/C10-30 Alkyl

Acrylate Crosspolymer,

Aminomethyl Propanol,

Fragrance (Parfum), Citral,

Limonene, Linalool

ID: 80-CHIOGAVHS

*organically grown aloe vera,

certification pending

Active Ingredients

Active ingredient Purpose

Ethyl Alcohol 77% v/v Antimicrobial

Route, Methos And Frequency Of Administration

Use for hand-washing to decrease bacteria on

the skin, only when water is not available.
Directions

wet hands

thoroughly with

product and allow

to dry without

wiping

for children

under 6, use only

under adult

supervision

Warnings And Precautions

Warnings

Flammable, keep away from fire and flames.

For external use only.

When using this product

do not get into eyes

if contact occurs, rinse eyes

thoroughly with water

Stop use and ask a doctor if:

irritation and redness

develop

Keep out of reach of

children. If swallowed,

get medical help or

contact a Poison

Control Center right

away

Storage And Handling

Other information

Do not store at

temperatures above

105°F

Indications & Usage

Use for hand-washing to decrease bacteria on

the skin, only when water is not available.
Directions

wet hands

thoroughly with

product and allow

to dry without

wiping

for children

under 6, use only

under adult

supervision

Warnings

Warnings

Flammable, keep away from fire and flames.

For external use only.

When using this product

do not get into eyes

if contact occurs, rinse eyes

thoroughly with water

Stop use and ask a doctor if:

irritation and redness

develop

Keep out of reach of

children. If swallowed,

get medical help or

contact a Poison

Control Center right

away

Otc - Keep Out Of Reach Of Children

Keep out of reach of

children. If swallowed,

get medical help or

contact a Poison

Control Center right

away

Purpose

Use for hand-washing to decrease bacteria on

the skin, only when water is not available.

* Please review the disclaimer below.