NDC 76412-001 Lysol Hand Sanitizer

Alcohol

NDC Product Code 76412-001

NDC 76412-001-01

Package Description: 59 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Lysol Hand Sanitizer with NDC 76412-001 is a a human over the counter drug product labeled by Reckitt Benckiser Llc. The generic name of Lysol Hand Sanitizer is alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Reckitt Benckiser Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Lysol 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 70 g/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.

  • WATER (UNII: 059QF0KO0R)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • 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: Reckitt Benckiser Llc
Labeler Code: 76412
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: 10-05-2020 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.

Lysol Hand Sanitizer Product Label Images

Lysol 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

Other

Drug Facts

Distributed by:Reckitt BenckiserParsippany, NJ07054-0224

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease.Recommended for repeated use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.Flammable. Keep away from fire or flame.For external use only, do not ingest. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

When using this product do not use in or near the eyes. In case of contact, rinse the eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Directions

  • Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.Children under 6 years of age should be supervised when using this product.

Other Information

Store below 110°F (43°C)

Inactive Ingredients

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice

Questions?

1-800-228-4722

* Please review the disclaimer below.