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Product NDC Code | 78641-688 | ||||||
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Drug Name | Foaming alcohol hand sanitizer |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | SOLUTION | ||||||
RxCUI drug identifier | 247835 | ||||||
Application Number | part333A | ||||||
Labeler Name | Global Equipment Company | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient - Ethyl Alcohol 62% 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 Apply small amount to palm. Briskly rub, covering hands with product until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients - Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, 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 on the skin that could cause disease.
Purpose
Information about the drug product’s indications for use.Purpose - Antbacterial Agent
Spl product data elements
Usually a list of ingredients in a drug product.Foaming Alcohol Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER ALOE VERA LEAF GLYCERIN .ALPHA.-TOCOPHEROL ACETATE, D- PEG-10 DIMETHICONE (600 CST) DISODIUM EDTA-COPPER CU-64 ISOPROPYL MYRISTATE POLYQUATERNIUM-11 (1000000 MW)
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.Primary 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. If swallowed, contact a physician or poison control center.
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 flames. Avoid contact with eyes. If eye contact occurs, flush with water. Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
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