NDC 35000-098 Softsoap Antibacterial Kitchen Fresh Hands

Benzalkonium Chloride Liquid

NDC Product Code 35000-098

NDC CODE: 35000-098

Proprietary Name: Softsoap Antibacterial Kitchen Fresh Hands What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride Liquid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 35000 - Colgate-palmolive
    • 35000-098 - Softsoap Antibacterial Kitchen Fresh Hands

NDC 35000-098-11

Package Description: 332 mL in 1 BOTTLE

NDC Product Information

Softsoap Antibacterial Kitchen Fresh Hands with NDC 35000-098 is a a human over the counter drug product labeled by Colgate-palmolive. The generic name of Softsoap Antibacterial Kitchen Fresh Hands is benzalkonium chloride liquid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Colgate-palmolive

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Softsoap Antibacterial Kitchen Fresh Hands 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 1.33 mg/mL

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)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Colgate-palmolive
Labeler Code: 35000
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: 02-14-2020 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.

Softsoap Antibacterial Kitchen Fresh Hands Product Label Images

Softsoap Antibacterial Kitchen Fresh Hands 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

DIST. BY:COLGATE-PALMOLIVE COMPANY,NEW YORK, NY 10022 USA

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

Helps eliminate bacteria on hands

Warnings

For external use only

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash hands and rinse

Inactive Ingredients

Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, Fragrance, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, PEG-40 Hydrogenated Castor Oil, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33, Yellow 5.

Questions?

1-800-255-7552

* Please review the disclaimer below.