NDC 80029-009 Protectme Antiseptic Hand Sanitizer

Alcohol

NDC Product Code 80029-009

NDC 80029-009-01

Package Description: 60 mL in 1 BOTTLE

NDC 80029-009-02

Package Description: 100 mL in 1 BOTTLE

NDC 80029-009-03

Package Description: 250 mL in 1 BOTTLE

NDC 80029-009-06

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC 80029-009-07

Package Description: 860 mL in 1 BOTTLE, PUMP

NDC 80029-009-09

Package Description: 3800 mL in 1 JUG

NDC 80029-009-10

Package Description: 5000 mL in 1 JUG

NDC Product Information

Protectme Antiseptic Hand Sanitizer with NDC 80029-009 is a a human over the counter drug product labeled by Lnw Protection Llc. The generic name of Protectme Antiseptic Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Lnw Protection 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.

Protectme Antiseptic 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 75 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • 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: Lnw Protection Llc
Labeler Code: 80029
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: 09-21-2020 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.

Protectme Antiseptic Hand Sanitizer Product Label Images

Protectme Antiseptic 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:LNW PROTECTION LLC1191 NEWPORT CENTER DR SUITE 103DEERFIELD BEACH, FL 33442INFO@PROTECTMESANITIZER.COM

Otc - Active Ingredient

Active ingredientAlcohol 75%

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • Usesto decrease bacteria on the skinrecommended for repeated use

Warnings

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

Otc - When Using

When using this product keep away from eyes. In case of contact, flush eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or redness develop or persist for more than 72 hours.

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.

Dosage & Administration

  • Directionswet hands thoroughly with productallow to dry without wipingsupervise children under 6 years oldnot recommended for infants

Storage And Handling

  • Other informationstore between 15°-30°C (59°-86°F).do not store above 40ºC (104ºF)may discolor some fabrics

Inactive Ingredient

Inactive IngredientsWater, Carbomer, Aminomethyl Propanol, Propylene Glycol, Aloe Vera Leaf Extract, Denatonium benzoate

* Please review the disclaimer below.