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| Product NDC Code | 83584-225 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizer foam |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 616805 | ||||
| Application Number | M003 | ||||
| Labeler Name | PurCel Labs 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 Ethyl Alcohol 70% v/v
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 • Put enough product in your palm to cover hands and rub hands together until dry. • Children under 6 years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Peg-10 Dimethicone, Aloe Barbadensis Extract, Glycerin, Propylene Glycol, Peg-7 Glyceryl Cocoate, Tocopheryl Acetate.
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 Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.Hand Sanitizer FOAM Ethanol alcohol ALCOHOL ALCOHOL PROPYLENE GLYCOL WATER PEG-10 DIMETHICONE (600 CST) ALOE VERA LEAF PEG-7 GLYCERYL COCOATE GLYCERIN ALPHA-TOCOPHEROL ACETATE
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.83584-225-01 83584-225-02 83584-225-03
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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 • On children less than 2 months of age. • On open skin wounds.
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.
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 do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store below 110°F (43°C). • Avoid freezing and excessive heat above 104°F (40°C). • May discolor certain fabrics or surfaces.
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. Flammable. Keep away from heat or flame.
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