NDC 80948-006 Puroma Antibacterial Hand Wash Fragrance Free

Benzalkonium Chloride

NDC Product Code 80948-006

NDC 80948-006-01

Package Description: 4 PACKAGE in 1 PACKAGE > 178 mL in 1 PACKAGE

NDC 80948-006-02

Package Description: 6 PACKAGE in 1 PACKAGE > 178 mL in 1 PACKAGE

NDC 80948-006-03

Package Description: 8 PACKAGE in 1 PACKAGE > 178 mL in 1 PACKAGE

NDC 80948-006-04

Package Description: 12 PACKAGE in 1 PACKAGE > 178 mL in 1 PACKAGE

NDC 80948-006-05

Package Description: 24 PACKAGE in 1 PACKAGE > 178 mL in 1 PACKAGE

NDC 80948-006-06

Package Description: 2 BOTTLE in 1 PACKAGE > 237 mL in 1 BOTTLE

NDC 80948-006-07

Package Description: 4 BOTTLE in 1 PACKAGE > 237 mL in 1 BOTTLE

NDC 80948-006-08

Package Description: 6 BOTTLE in 1 PACKAGE > 237 mL in 1 BOTTLE

NDC 80948-006-09

Package Description: 8 BOTTLE in 1 PACKAGE > 237 mL in 1 BOTTLE

NDC 80948-006-10

Package Description: 12 BOTTLE in 1 PACKAGE > 237 mL in 1 BOTTLE

NDC 80948-006-11

Package Description: 24 BOTTLE in 1 PACKAGE > 237 mL in 1 BOTTLE

NDC 80948-006-12

Package Description: 2 BOTTLE in 1 PACKAGE > 326 mL in 1 BOTTLE

NDC 80948-006-13

Package Description: 4 BOTTLE in 1 PACKAGE > 326 mL in 1 BOTTLE

NDC 80948-006-14

Package Description: 6 BOTTLE in 1 PACKAGE > 326 mL in 1 BOTTLE

NDC 80948-006-15

Package Description: 8 BOTTLE in 1 PACKAGE > 326 mL in 1 BOTTLE

NDC 80948-006-16

Package Description: 12 BOTTLE in 1 PACKAGE > 326 mL in 1 BOTTLE

NDC 80948-006-17

Package Description: 24 BOTTLE in 1 PACKAGE > 326 mL in 1 BOTTLE

NDC 80948-006-18

Package Description: 2 BOTTLE in 1 PACKAGE > 474 mL in 1 BOTTLE

NDC 80948-006-19

Package Description: 4 BOTTLE in 1 PACKAGE > 474 mL in 1 BOTTLE

NDC 80948-006-20

Package Description: 6 BOTTLE in 1 PACKAGE > 474 mL in 1 BOTTLE

NDC 80948-006-21

Package Description: 8 BOTTLE in 1 PACKAGE > 474 mL in 1 BOTTLE

NDC 80948-006-22

Package Description: 12 BOTTLE in 1 PACKAGE > 474 mL in 1 BOTTLE

NDC 80948-006-23

Package Description: 24 BOTTLE in 1 PACKAGE > 474 mL in 1 BOTTLE

NDC 80948-006-24

Package Description: 2 BOTTLE in 1 PACKAGE > 947 mL in 1 BOTTLE

NDC 80948-006-25

Package Description: 4 BOTTLE in 1 PACKAGE > 947 mL in 1 BOTTLE

NDC 80948-006-26

Package Description: 5000 mL in 1 CAN

NDC 80948-006-27

Package Description: 50000 mL in 1 CAN

NDC 80948-006-28

Package Description: 200000 mL in 1 DRUM

NDC Product Information

Puroma Antibacterial Hand Wash Fragrance Free with NDC 80948-006 is a a human over the counter drug product labeled by Zenith Micro Control. The generic name of Puroma Antibacterial Hand Wash Fragrance Free is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Zenith Micro Control

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.

Puroma Antibacterial Hand Wash Fragrance Free 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 130 mg/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)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)

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: Zenith Micro Control
Labeler Code: 80948
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: 03-05-2021 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: 12-31-2022 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 - NO 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.

Puroma Antibacterial Hand Wash Fragrance Free Product Label Images

Puroma Antibacterial Hand Wash Fragrance Free 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

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings

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


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

Keep Out Of Reach Of Children

Except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands and wrists with clean running water


• Apply appropriate amount of product


• Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly


• Rinse thoroughly with running water


• Dry hands completely.

Inactive Ingredients

Water, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Sodium Chloride, Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide, Behentrimonium Chloride PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Glycol Distearate, Polysorbate 20.

Other Information

• Store below 104°F (40°C)

* Please review the disclaimer below.