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Benzalkonium chloride - Medication Information

Product NDC Code 78691-140
Drug Name

Benzalkonium chloride

Type Brand
Active Ingredients
Benzalkonium chloride .13 g/1001
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 1038558
Application Number M003
Labeler Name Quest USA Corp
Packages
Package NDC Code Description
78691-140-04 1400 cloth in 1 container (78691-140-04)
78691-140-06 1600 cloth in 1 container (78691-140-06)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium Chloride 0.13%

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 Apply to hands, allow to air dry without wiping. Children under 6 years of age should be supervised when using this product.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis Leaf Extract, Citric Acid, Decyl Glucoside, Disodium EDTA, Fragrance, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Benzoate

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 Hand sanitizer to help reduce bacteria For use when soap and water are not available

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.
Benzalkonium Chloride Antibacterial Hand Wipes CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS POTASSIUM SORBATE PHENOXYETHANOL WATER SODIUM BENZOATE DECYL GLUCOSIDE BENZALKONIUM CHLORIDE BENZALKONIUM ALOE VERA LEAF

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.
1600fr 1600Ba 1400New

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 in children less than 2 months old. on open skin wounds.

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information Store in a cool, dry place, between 15°-30°C (59°F-86°F). Avoid freezing and excessive heat above 40°C (104°F).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call 718-975-2586

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 or rash occurs. These may be signs of serious condition.

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 keep out of eyes, ears, and mouth. In case of contact with eyes, 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. Do not use in children less than 2 months old. on open skin wounds. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition. 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