NDC 77009-0420 Caren Hand Sanitizer Antiseptic

Benzalkonium Chloride

NDC Product Code 77009-0420

NDC 77009-0420-1

Package Description: .059 kg in 1 TUBE

NDC 77009-0420-2

Package Description: .118 kg in 1 TUBE

NDC 77009-0420-3

Package Description: .948 kg in 1 BOTTLE, PUMP

NDC Product Information

Caren Hand Sanitizer Antiseptic with NDC 77009-0420 is a a human over the counter drug product labeled by Caren Products, Llc. The generic name of Caren Hand Sanitizer Antiseptic is benzalkonium chloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Caren Products, 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.

Caren Hand Sanitizer Antiseptic 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 .0013 kg/kg

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ALOE (UNII: V5VD430YW9)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Caren Products, Llc
Labeler Code: 77009
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: 05-28-2020 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.

Caren Hand Sanitizer Antiseptic Product Label Images

Caren Hand Sanitizer Antiseptic 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

Active Ingredient(S)

Benzalkonium Chloride....................Purpose: Antimicrobial and First Aid Antiseptic

Purpose

Antimicrobial and First Aid Antiseptic

Uses

  • For hand sanitizing to decrease bacteria on the skin.  Recommended for repeated use.  For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations, and sking infections.

Warnings

For external use only.

Otc - When Using

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

Otc - Stop Use

Discontinue use if irratation or redness develops.  If condition persists for more than 72 hours consult a doctor.

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.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.Antiseptic: Apply to cuts, scrapes, and burns 3 times a day after cleaning.  Allow to dry.

Inactive Ingredients

Aloe, Carbomer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

* Please review the disclaimer below.