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| Product NDC Code | 30805-018 | ||||
|---|---|---|---|---|---|
| Drug Name | Altra antimicrobial foaming hand wash w/ benzalkonium chloride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1046593 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Buckeye International, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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.Directions Wet hands and wrists Dispense an adequate amount of soap and vigorously wash hands Rinse hands thoroughly with clean or potable water Dry hands completely
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Cetrimonium Chloride, Tetrasodium EDTA, Phenoxyethanol, Citric Acid.
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 wash to help reduce bacteria on skin Recommended for repeated use
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.Altra Antimicrobial Foaming Hand Wash w/ Benzalkonium Chloride Benzalkonium Chloride PHENOXYETHANOL BENZALKONIUM CHLORIDE BENZALKONIUM CITRIC ACID MONOHYDRATE WATER TETRASODIUM EDTA CETRIMONIUM CHLORIDE
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.Low Profile ALTRA Antimicrobial Foaming Hand Wash w/ Benzalkonium Chloride Hand Hygiene NET CONTENTS 1000 mL (33.8 fl oz) container label
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, call a physician or Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call: Buckeye International, Inc. 314-291-1900 Monday through Friday 8:00 a.m. to 5:00 p.m. CST
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.If irritation or rash appears and persists, stop use and see a physician.
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 use in or near eyes. If in eyes, flush thoroughly with water.
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. When using this product do not use in or near eyes. If in eyes, flush thoroughly with water. If irritation or rash appears and persists, stop use and see a physician. Keep out of reach of children. If swallowed, call a physician or Poison Control Center immediately.
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