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| Product NDC Code | 59448-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzalkonium chloride |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1038558 | ||||
| Application Number | part333E | ||||
| Labeler Name | ASP Global, LLc | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 Apply topically as needed to clean intended area. Discard after single use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Ethylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Sodium Citrate, 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.Use for preparation of the skin prior to an injection.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE Benzalkonium ALOE VERA LEAF Water ETHYLPARABEN PHENOXYETHANOL DMDM HYDANTOIN POLYSORBATE 20 EDETATE DISODIUM ANHYDROUS METHYLPARABEN SODIUM CITRATE, UNSPECIFIED FORM
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.PRINCIPAL DISPLAY PANEL - 10 Applicator Package BaylorScott&White HEALTH OPEN Principal Display Panel - 10 Applicator Package
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.Drug Facts
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 immediately.
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. Flammable, keep away from fire or flame. Do not use with electrocautery procedures or near eyes. Stop use and ask a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a 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