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| Product NDC Code | 83535-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Biopure 1400ct antibacterial hand wipes |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1038741 | ||||
| Application Number | M003 | ||||
| Labeler Name | QUANZHOU YUELIANGYUAN BIOTECHNOLOGY 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 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