NDC 59900-127 Softensure Foam Antimicrobial

Chloroxylenol

NDC Product Code 59900-127

NDC 59900-127-05

Package Description: 1250 mL in 1 BOX

NDC Product Information

Softensure Foam Antimicrobial with NDC 59900-127 is a a human over the counter drug product labeled by Best Sanitizers, Inc.. The generic name of Softensure Foam Antimicrobial is chloroxylenol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Best Sanitizers, Inc.

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.

Softensure Foam Antimicrobial 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.

  • CHLOROXYLENOL 10 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)
  • POTASSIUM COCOATE (UNII: F8U72V8ZXP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Best Sanitizers, Inc.
Labeler Code: 59900
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: 05-15-2019 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: 12-31-2020 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.

Softensure Foam Antimicrobial Product Label Images

Softensure Foam Antimicrobial 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

Otc - Active Ingredient

Active ingredientChloroxylenol 1.0%

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • Useshandwash to help reduce bacteria that potentially can cause diseasehelps to prevent cross-contamination by hand contacthelps to prevent drying of the skinrecommended for repeated use

Warnings

WarningsFor external use only

Otc - When Using

When using this productdo not use in or near eyes

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, seek medical attention or contact a Poison Control Center immediately.

Dosage & Administration

  • Directionswet hands and wrists with clean, running waterapply appropriate amount of productlather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 secondsrinse thoroughly with running waterdry hands completely (incomplete drying may result in chapped skin)

Storage And Handling

Other informationstore in a cool, dry place below 104o F (40o C)

Inactive Ingredient

Inactive ingredientsWater, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

Otc - Questions

Questions?Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

* Please review the disclaimer below.