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| Product NDC Code | 79794-112 | ||||
|---|---|---|---|---|---|
| Drug Name | Biopure 1600ct antibacterial hand wipes |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1038741 | ||||
| Application Number | part333E | ||||
| Labeler Name | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 0.12% Benzalkonium Chloride
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 1600CT ANTIBACTERIAL HAND WIPES Benzalkonium Chloride PROPYLENE GLYCOL PHENOXYETHANOL WATER BENZALKONIUM CHLORIDE BENZALKONIUM GLYCERIN
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 CT 1600
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if irritation or rash appears and lasts.
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.
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 do not get in eyes. If contact is made rinse 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.
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