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| Product NDC Code | 55316-403 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hand wash |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOAP | ||||||
| RxCUI drug identifier | 1046593 | ||||||
| Application Number | part333A | ||||||
| Labeler Name | DZA Brands, 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%
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 apply palmful to hands scrub thoroughly rinse thoroughly
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, myristamidopropylamine oxide, PEG-120 methyl glucose dioleate, fragrance, sodium sulfate, sodium chloride, citric acid, tetrasodium EDTA, phenoxyethanol, methylisothiazolinone, yellow 5, red 4
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 handwashing to decrease bacteria on the skin
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.Hand wash Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER LAURAMINE OXIDE COCAMIDOPROPYL BETAINE LAURAMIDOPROPYLAMINE OXIDE SODIUM CHLORIDE MYRISTAMIDOPROPYLAMINE OXIDE GLYCERIN DISTEARETH-75 ISOPHORONE DIISOCYANATE PEG-150 DISTEARATE CITRIC ACID MONOHYDRATE EDETATE SODIUM SULISOBENZONE SODIUM BENZOATE FD&C RED NO. 4 FD&C YELLOW NO. 5
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 healthy accents antibacterial hand soap 56 FL OZ (1.65 L) image description
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.DISTRIBUTED BY: DZA BRANDS, LLC 2110 Executive Drive Salisbury, NC 28147 For product questions or concerns, contact us at 1-866-322-2439 Please include UPC number and code from package
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-213-904
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 redness develops condition persists for more than 72 hours
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 avoid contact with eyes. If contact occurs, rinse eyes 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-hands only
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