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| Product NDC Code | 81353-026 | ||||
|---|---|---|---|---|---|
| Drug Name | Guardex sanitizing hand |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part333A | ||||
| Labeler Name | Nile Hudson 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 Ingredients Benzalkonium Chloride 0.095%
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 Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Caprylic/Capric Glycerides, Ethylhexyl Palmitate, Ammonium Polyacrylate, C13-C16 Isoparaffin, Laurath-30, Phenoxyethanol, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Fragrance, Panthenol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Maltodextrin.
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 cleaning reduce bacteria that potentially can cause disease and moisture your hands.
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.GUARDEX SANITIZING HAND BENZALKONIUM CHLORIDE MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES WATER ETHYLHEXYL PALMITATE SHEA BUTTER BENZALKONIUM CHLORIDE BENZALKONIUM ALOE VERA LEAF LAURETH-30 PHENOXYETHANOL C13-16 ISOPARAFFIN AMINOMETHYLPROPANOL PANTHENOL CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN
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.image of tube label
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 In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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 Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not store above 105 °F May discolor some fabrics
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
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