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Antimicrobial hand wash - Medication Information

Product NDC Code 0404-5987
Drug Name

Antimicrobial hand wash

Type Brand
Active Ingredients
Chloroxylenol 6 mg/1000ml
Route TOPICAL
Dosage Form SOAP
Application Number part333A
Labeler Name Henry Schein, Inc.
Packages
Package NDC Code Description
0404-5987-01 800 ml in 1 box (0404-5987-01)
0404-5987-02 1.68 ml in 1 pouch (0404-5987-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Chloroxylenol (PCMX) 0.6%

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 forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 30 seconds supervise children under 6 years of age

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA Made in U.S.A.

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 for handwashing to decrease bacteria on 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.
Antimicrobial Hand Wash Chloroxylenol chloroxylenol chloroxylenol aloe vera leaf coco diethanolamide cocamidopropyl betaine diazolidinyl urea propylene glycol water sodium chloride sodium laureth sulfate edetate sodium alpha-tocopherol acetate propylparaben methylparaben

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.
PRINCIPAL DISPLAY PANEL – 800 mL Box Henry Schein 112-5987 Maxiclens Antimicrobial Hand Wash NDC 0404-5987-01 27.05 FL. OZ. (800 ML) PRINCIPAL DISPLAY PANEL – 800 mL Box PRINCIPAL DISPLAY PANEL – 1.68 mL Packet Henry Schein Maxiclens Antimicrobial Hand Wash With PCMX To Order: Contact your Henry Schein Sales Rep 0.0570 fl.oz. (1.68 ML) Distributed by HENRY SCHEIN, Inc. Melville, NY 11747 USA Made in U.S.A. PRINCIPAL DISPLAY PANEL – 1.68 mL Packet

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

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

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 doctor if irritation and redness develops and persists for more than 72 hours

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 get into eyes. If contact occurs, rinse eyes thoroughly with water

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 get into eyes. If contact occurs, rinse eyes thoroughly with water Stop use and ask doctor if irritation and redness develops and persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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