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Safeguard antibacterial hand - Medication Information

Product NDC Code 69423-053
Drug Name

Safeguard antibacterial hand

Type Brand
Active Ingredients
Chloroxylenol .5 mg/100ml
Route TOPICAL
Dosage Form LIQUID
Application Number 505G(a)(3)
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-053-30 300 ml in 1 bottle, pump (69423-053-30)
69423-053-37 3780 ml in 1 bottle, pump (69423-053-37)
69423-053-80 800 ml in 1 pouch (69423-053-80)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Chloroxylenol 0.5%

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 20 seconds and rinse.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, sodium lauryl sulfate, sodium laureth sulfate, cocamide MEA, phenoxyethanol, glycol distearate, cocamidopropyl betaine, sodium sulfate, citric acid, fragrance, guar hydroxypropyltrimonium chloride, DMDM hydantoin, tetrasodium EDTA, yellow 5, red 4

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.
Use For handwashing to decrease bacteria on skin. Recommended for repeated use.

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Safeguard Antibacterial Hand Chloroxylenol PHENOXYETHANOL EDETATE SODIUM GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) WATER SODIUM LAURYL SULFATE SODIUM LAURETH-3 SULFATE COCO MONOETHANOLAMIDE GLYCOL DISTEARATE COCAMIDOPROPYL BETAINE SODIUM SULFATE CITRIC ACID MONOHYDRATE DMDM HYDANTOIN FD&C YELLOW NO. 5 FD&C RED NO. 4 CHLOROXYLENOL CHLOROXYLENOL

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 - 3.78 L Bottle Label Liquid Ready-to-Use Safeguard ™ Antibacterial Hand Soap Helps remove bacteria from skin Chloroxylenol Antibacterial Hand Soap 3.78 L/1 GALLON safeguard

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 Distr. by PROCTER & GAMBLE, CINCINNATI, OH 45202.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use this product on infants under 6 months of age.

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

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-332-7787 (professional sizes) 1-800-595-1375 (personal size)

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 if irritation occurs.

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 avoid contact with eyes. If this happens, rinse 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. Do not use this product on infants under 6 months of age. When using this product avoid contact with eyes. If this happens, rinse thoroughly with water. Stop use if irritation occurs. Keep out of reach of children, except under adult supervision. 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