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Product NDC Code | 71020-001 | ||||||
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Drug Name | Antibacterial |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 1046593 | ||||||
Application Number | part333A | ||||||
Labeler Name | Sante Manufacturing Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)
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 handwashing or decrease bacteria to 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.Antibacterial Benzalkonium Chloride GLYCERIN DITETRACYCLINE TETRASODIUM EDETATE METHYLCHLOROISOTHIAZOLINONE WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE SODIUM CHLORIDE ANHYDROUS CITRIC ACID METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 FD&C RED NO. 4 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.Regular Antibacterial Liquid Soap
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 or redness develops
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 the product do not get into eyes. If contact occurs, rinse eye 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.For external use 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