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| Product NDC Code | 90119-001 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Rough and smooth heavy duty antiseptic hand sanitizer |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CLOTH | ||||||||
| RxCUI drug identifier | 1038558 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Orbizorb LLC | ||||||||
| 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 0.13% Purpose Antiseptic
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 Peel back the foil seal and pull the center wipe through the slot in the lid. Wet hands thoroughly with product and allow to dry without wiping. Close lid after use to prevent wipes from drying out.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.
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 hand washing to decrease bacteria on the skin
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.Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE WATER POLOXALENE PEG-75 LANOLIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED LAURYL GLUCOSIDE EDETATE DISODIUM ANHYDROUS BRONOPOL ALOE VERA LEAF 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 Labeling: Updated 80ct Label
Package Labeling:2wipes Label
Package Labeling:40wipes Label2
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
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 the eyes
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 and redness develop. If condition persists for more than 72 hours consult a doctor.
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 the eyes Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. 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