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| Product NDC Code | 60933-106 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Simple hygiene antibacterial foam hand |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SOAP | ||||||||
| RxCUI drug identifier | 436367 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Fuller Industries, 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 Chloroxylenol 0.5% 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 Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together to produce a thick lather Rinse and repeat
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingerdients Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Yellow No. 6, D&C Red No. 33, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Oletin Sulfonate, 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 For hand washing to decrease the bacteria on skin. Recommended for repeated use
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.Simple Hygiene Antibacterial Foam Hand CHLOROXYLENOL ALOE VERA LEAF CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS FD&C YELLOW NO. 6 D&C RED NO. 33 ISOPROPYL ALCOHOL LAURAMINE OXIDE PROPYLENE GLYCOL WATER CHLOROXYLENOL CHLOROXYLENOL
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:60933-106-01 Label
Package Labeling:60933-106-02 Label2
Package Labeling:60933-106-03 Label3
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. In case of contact, flush eyes with water.
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 irritatation and redness develop condition persists for more than 72 hours
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. In case of contact, flush eyes with water. Stop use and ask a doctor if irritatation and redness develop condition persists for more than 72 hours 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