NDC 10596-717 Jergens Moisture Care Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 10596-717

NDC 10596-717-30

Package Description: 88 mL in 1 TUBE

NDC 10596-717-75

Package Description: 221 mL in 1 TUBE

NDC Product Information

Jergens Moisture Care Hand Sanitizer with NDC 10596-717 is a a human over the counter drug product labeled by Kao Usa Inc.. The generic name of Jergens Moisture Care Hand Sanitizer is benzalkonium chloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Kao Usa Inc.

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.

Jergens Moisture Care 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.

  • BENZALKONIUM CHLORIDE .13 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.

  • BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
  • ALCOHOL (UNII: 3K9958V90M)
  • HYDROXYETHYL PALMITYL OXYHYDROXYPROPYL PALMITAMIDE (UNII: ISA73Z2140)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)

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: Kao Usa Inc.
Labeler Code: 10596
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: 01-01-2021 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: 12-31-2021 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.

Jergens Moisture Care Hand Sanitizer Product Label Images

Jergens Moisture Care 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

*
kills 99.9% of common harmful germs such as bacteriaQuestions or comments? Jergens Skincare Experts are always at your fingertips: www.jergens.com or call 1-800-742-8798JERGENS is a trademark of Kao Corp.Distributed by Kao USA Inc., Cincinnati, OH 45214 ©2020Made in USA of US & Imported Ingredients

Otc - Active Ingredient

Active ingredientBenzalkonium chloride 0.13%

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • Usehand sanitizer to help reduce bacteria on the skinrecommended for repeated use

Warnings

WarningsFor external use only

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask a doctor ifirritation or redness develops.conditions persist 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 product and allow to dry without wipingchildren under 6 years of age should be supervised when using this productnot recommended for infants

Storage And Handling

Other information store at room temperature

Inactive Ingredient

Inactive ingredients water, glycerin, petrolatum, cetearyl alcohol, isopropyl palmitate, behentremonium chloride, paraffin, stearyl alcohol, dimethicone, aluminum starch octenylsuccinate, isopropyl alcohol, fragrance, alcohol, cetyl-PG hydroxyethyl palmitamide, cocos nucifera (coconut) oil, tocopheryl acetate, butylene glycol, eucalyptus globulus leaf extract, methylparaben, ethylparaben

* Please review the disclaimer below.