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Antiseptic wipe - Medication Information

Product NDC Code 83165-002
Drug Name

Antiseptic wipe

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 1038558
Application Number 505G(a)(3)
Labeler Name Hubei Fanjian Medical Product Co.,Ltd
Packages
Package NDC Code Description
83165-002-00 .62 ml in 1 patch (83165-002-00)
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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 Tand 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 ingredients 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 preparation of the skin before injection. 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 Wipe 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: Label4

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 Other information: Store at room temperature15°-30° C (59°-86° F)

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