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Antiseptic towelette - Medication Information

Product NDC Code 50814-002
Drug Name

Antiseptic towelette

Type Brand
Active Ingredients
Benzalkonium chloride .13 g/100g
Route TOPICAL
Dosage Form SWAB
RxCUI drug identifier 1038558
Application Number M003
Labeler Name GFA Production (Xiamen) Co., Ltd.
Packages
Package NDC Code Description
50814-002-01 1 pouch in 1 box (50814-002-01) / .45 g in 1 pouch
50814-002-02 1 pouch in 1 box (50814-002-02) / .25 g in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient: Benzalkonium Chloride 0.13% Purpose: First Aid Antiseptic

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: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredient: Purified water.

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 Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Antiseptic Towelette BENZALKONIUM CHLORIDE WATER BENZALKONIUM CHLORIDE BENZALKONIUM

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.
Package Labeling: Label1

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

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 the eyes, or over large areas of the body.

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. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately. Do not use: In the eyes, or over large areas of the body.

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