NDC 81495-112 Issengard 24 Hand Sanitizer 3 Oz

Benzalkonium Chloride

NDC Product Code 81495-112

NDC 81495-112-03

Package Description: 89 mL in 1 TUBE

NDC Product Information

Issengard 24 Hand Sanitizer 3 Oz with NDC 81495-112 is a a human over the counter drug product labeled by Clear Lake Research, Llc. The generic name of Issengard 24 Hand Sanitizer 3 Oz is benzalkonium chloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Clear Lake Research, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Issengard 24 Hand Sanitizer 3 Oz 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.

  • BENZALKONIUM CHLORIDE .18 mg/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.

  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • OCTOXYNOL-1 (UNII: 20CAX7IO75)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Clear Lake Research, Llc
Labeler Code: 81495
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: 03-22-2021 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: 12-31-2022 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 - NO 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.

Issengard 24 Hand Sanitizer 3 Oz Product Label Images

Issengard 24 Hand Sanitizer 3 Oz 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

DRUG FACTS

Active Ingredients

Benzalkonium Chloride, 0.18%

Purpose Section

Antimicrobial

Warnings

For external uses only

Uses

  • To help reduce germs on the skinRecommended use once a day or as needed

When Using Section

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

Stop use and ask a doctor if rash, irritation, or other allergic reaction occurs

Keep Out Of Reach Of Children Section

Keep out of reach of children, if the product is swallowed, get medical help or contact a Poison Center right away.

Directions

Apply half an inch each morning on clean skin

Inactive Ingredients

Water (Aqua), Glycine soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Tributyl Phosphate, Glycerin, t-Octylphenoxy-polyethoxyethanol, Hydroxy- ethylacrylate/Sodium Acryloyldimethyl Taurate, Copolymer, Isohexadecane, Polysorbate 60, Glyceryl Stearate, Stearic Acid, Stearyl Alcohol, Lavandula angustifolia (Lavender) Oil, Propylene Glycol, Ethyl Alcohol, Zinc Oxide CI 77947

* Please review the disclaimer below.