NDC 31507-876 Hand Guard High Foaming Antiseptic Hand And Body Wash
Chloroxylenol Soap Topical

Product Information

Hand Guard High Foaming Antiseptic Hand And Body Wash is a human over the counter drug product labeled by Wechem, Inc.. The generic name of Hand Guard High Foaming Antiseptic Hand And Body Wash is chloroxylenol. The product's dosage form is soap and is administered via topical form.

Product Code31507-876
Proprietary Name 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.
Hand Guard High Foaming Antiseptic Hand And Body Wash
Non-Proprietary Name 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.
Chloroxylenol
Product Type 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.
Human Otc Drug
Dosage FormSoap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.
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.
Wechem, Inc.
Labeler Code31507
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-04-2017
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Hand Guard High Foaming Antiseptic Hand And Body Wash?


Product Packages

NDC 31507-876-01

Package Description: 1200 mL in 1 CARTRIDGE

NDC 31507-876-03

Package Description: 350 mL in 1 CARTRIDGE

NDC 31507-876-05

Package Description: 540 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-06

Package Description: 1 BAG in 1 BOX > 800 mL in 1 BAG

NDC 31507-876-07

Package Description: 700 mL in 1 BAG

NDC 31507-876-08

Package Description: 1 BAG in 1 BOX > 1000 mL in 1 BAG

NDC 31507-876-09

Package Description: 2000 mL in 1 CARTRIDGE

NDC 31507-876-10

Package Description: 1000 mL in 1 CARTRIDGE

NDC 31507-876-11

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-12

Package Description: 1000 mL in 1 BAG

NDC 31507-876-13

Package Description: 800 mL in 1 BAG

NDC 31507-876-14

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-15

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-16

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-17

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-18

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-19

Package Description: 18900 mL in 1 CONTAINER

NDC 31507-876-20

Package Description: 75600 mL in 1 DRUM

NDC 31507-876-24

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-27

Package Description: 800 mL in 1 CARTRIDGE

NDC 31507-876-28

Package Description: 149 mL in 1 BOTTLE, PLASTIC

NDC 31507-876-35

Package Description: 132500 mL in 1 DRUM

NDC 31507-876-55

Package Description: 208200 mL in 1 DRUM

Product Details

What are Hand Guard High Foaming Antiseptic Hand And Body Wash Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Hand Guard High Foaming Antiseptic Hand And Body Wash Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Hand Guard High Foaming Antiseptic Hand And Body Wash Inactive Ingredients UNII Codes

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.

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Hand Guard High Foaming Antiseptic Hand And Body Wash Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Drug Facts Box Otc-Active Ingredient Section



Chloroxylenol 0.3%


Drug Facts Box Otc-Purpose Section



Antiseptic


Drug Facts Box Otc-Indications & Usage Section



for hand-washing to decrease bacteria on the skin


Drug Facts Box Otc-Warnings Section



For external use only


Drug Facts Box Otc-When Using Section



do not get into eyes

if contact occurs, rinse eyes thoroughly with water


Drug Facts Box Otc-Stop Use Section



irritation and redness develop


Drug Facts Box Otc-Keep Out Of Reach Of Children Section



if swallowed, get medical help or contact a Poison Control Center right away


Drug Facts Box Otc-Dosage & Administration Section



  • wet hands and forearms
  • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 1 minute and rinse

Drug Facts Box Otc-Inactive Ingredient Section



water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, aloe barbadensis, acid red 1


Hand Guard High Foaming Antiseptic Hand & Body Wash 6876



Hand Guard High Foaming Hand and Body Wash


* Please review the disclaimer below.