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Antiseptic sanitizing wipes - Medication Information

Product NDC Code 83666-001
Drug Name

Antiseptic sanitizing wipes

Type Brand
Active Ingredients
Benzalkonium chloride .013 g/g
Route TOPICAL
Dosage Form CLOTH
Application Number M003
Labeler Name ZHEJIANG WIPEX NEW MATERIAL TECHNOLOGY CO.,LTD
Packages
Package NDC Code Description
83666-001-01 900 g in 1 bag (83666-001-01)
83666-001-02 10 g in 1 bag (83666-001-02)
83666-001-03 1 g in 1 bag (83666-001-03)
83666-001-04 15 g in 1 bag (83666-001-04)
83666-001-05 50 g in 1 bag (83666-001-05)
83666-001-06 20 g in 1 bag (83666-001-06)
83666-001-07 100 g in 1 bag (83666-001-07)
83666-001-08 1200 g in 1 bag (83666-001-08)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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.
Wet hands thoroughly with product andallow to dry without wiping.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
water Glycerin Disodium Cocoamphodiacetate Phenoxyethanol Benzoic Acid Polysorbate 20 Potassium Sorbate Aloe barbadensia Leaf juice Benzalkonium Chloride Melaleuca Alternifolia (Tea Tree) Leaf Oil Menthol Sodium Citrate

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.
For hand washing to decrease bacteria on skin Recommended for repeated use.

Purpose

Information about the drug product’s indications for use.
For hand washing to decrease bacteria on skin Recommended for repeated use.

Spl product data elements

Usually a list of ingredients in a drug product.
ANTISEPTIC SANITIZING WIPES Benzalkonium Chloride 0.13% SODIUM CITRATE MENTHOL POLYSORBATE 20 BENZOIC ACID BENZALKONIUM CHLORIDE BENZALKONIUM POTASSIUM SORBATE MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL GLYCERIN PHENOXYETHANOL WATER ALOE VERA LEAF DISODIUM COCOAMPHODIACETATE

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.
label1 label2

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.
ANTISEPTIC SANITIZING WIPES

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.
In the eyes

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 contacta 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.
lrritation and redness develops Condition 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.
Wet hands thoroughly with product andallaw to dry without wiping.

Storage and handling

Information about safe storage and handling of the drug product.
Store below 104F(40°C) May discolor certain fabrics

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.
For external use only

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