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Biopure 1400ct antibacterial hand wipes - Medication Information

Product NDC Code 83535-008
Drug Name

Biopure 1400ct antibacterial hand wipes

Type Brand
Active Ingredients
Benzalkonium chloride .12 g/100g
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 1038741
Application Number M003
Labeler Name QUANZHOU YUELIANGYUAN BIOTECHNOLOGY CO.,LTD
Packages
Package NDC Code Description
83535-008-01 4 pouch in 1 carton (83535-008-01) / 1400 patch in 1 pouch / 1.8 g in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium Chloride 0.12%

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 Glycerin, Phenoxyethanol, Propylene Glycol, 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.
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.
BIOPURE 1400CT ANTIBACTERIAL HAND WIPES Benzalkonium Chloride PROPYLENE GLYCOL GLYCERIN PHENOXYETHANOL 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 label 1440art

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.
Question? Call 718-975-2586

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.

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 a 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information ●Store in a cool, dry place. ●Avoid freezing and excessive heat

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 a 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