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Softensure foam antimicrobial - Medication Information

Product NDC Code 59900-127
Drug Name

Softensure foam antimicrobial

Type Brand
Active Ingredients
Chloroxylenol 10 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 413257
Application Number part333A
Labeler Name Best Sanitizers, Inc.
Packages
Package NDC Code Description
59900-127-05 1250 ml in 1 box (59900-127-05)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Chloroxylenol 1.0%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions wet hands and wrists with clean, running water apply appropriate amount of product lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds rinse thoroughly with running water dry hands completely (incomplete drying may result in chapped skin)

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses handwash to help reduce bacteria that potentially can cause disease helps to prevent cross-contamination by hand contact helps to prevent drying of the skin recommended for repeated use

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
SoftenSure Foam Antimicrobial CHLOROXYLENOL CHLOROXYLENOL CHLOROXYLENOL WATER POTASSIUM COCOATE EDETATE SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
versaclenz compatible SoftenSure foam soap antimicrobial BEST SANITIZERS INC. Net Contents: container label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation and redness develop.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not use in or near eyes

Storage and handling

Information about safe storage and handling of the drug product.
Other information store in a cool, dry place below 104 o F (40 o C)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only When using this product do not use in or near eyes Stop use and ask a doctor if irritation and redness develop. Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API