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Product NDC Code | 69771-002 | ||||
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Drug Name | Antimicrobial alcohol hand |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Geri-Gentle Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Alcohol 65.9% by volume Purpose Antiseptic
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 To start feed: Remove cover and discard seal from container. From center of toweled roll, pull up wipe corner, tear off fist wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at 90° angle. Keep cap closed to prevent moisture loss Wipe hands , fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe, Sanitize with a second wipe Discard after single use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Propylene Glycol, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Tetrasodium EDTA
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 Antiseptic For handwashing to decrease bacteria on the skin, assisting ill persons, and before contact with a person under medical care or treatment Apply topically to the skin to help prevent cross-contamination Recommended for repeated use Dries in seconds
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.Antimicrobial Alcohol Hand ALCOHOL WATER PROPYLENE GLYCOL CARBOXYPOLYMETHYLENE TROLAMINE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE EDETATE SODIUM ALCOHOL ALCOHOL
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.Package Labeling: Label 2
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.Drug Facts
Other information Lot No. and Expiration Date can be found on canister
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 in or make contact with the eyes Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a physician
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 this our of reach of children unless under adult supervision If swallowed, get medical help or contact a Poison Center immediately
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 Flammable, keep away from fire or flame For external use only Do not use in or make contact with the eyes Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a physician Keep this our of reach of children unless under adult supervision If swallowed, get medical help or contact a Poison Center immediately
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