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| Product NDC Code | 83986-858 | ||||
|---|---|---|---|---|---|
| Drug Name | Benzalkonium chloride |
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| Type | Generic | ||||
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | UpLift Brands, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction Distributed by: Vi-Jon, LLC, St. Louis, MO 63114
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, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, limonene, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, orange 4, red 33
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.Benzalkonium chloride Benzalkonium chloride WATER LAURAMINE OXIDE COCAMIDOPROPYL BETAINE LAURAMIDOPROPYLAMINE OXIDE SODIUM CHLORIDE MYRISTAMIDOPROPYLAMINE OXIDE GLYCERIN LIMONENE, (+)- DISTEARETH-75 ISOPHORONE DIISOCYANATE PEG-150 DISTEARATE CITRIC ACID ACETATE EDETATE SODIUM SULISOBENZONE SODIUM BENZOATE D&C ORANGE NO. 4 D&C RED NO. 33 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.Principal display panel germ-X SINCE 1997 ANTIBACTERIAL HAND SOAP CITRUS PEEL SCENT WASHES AWAY GERMS* pH Balanced, Dermatologist Tested FORMULA MADE IN USA EMPLOYEE-OWNED 16 FL OZ (473 mL) 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.Claims ANTIBACTERIAL HAND SOAP
Claims *Washing hands helps wash away bacteria and germs FORMULA MADE IN USA EMPLOYEE-OWNED
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 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: hand 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