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Product NDC Code | 54622-148 | ||||
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Drug Name | Hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1038791 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Georgia Pacific Consumer Products | ||||
Packages |
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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 Manufacture for Georgia-Pacific Consumer Products LP. Altanta, GA 30303 Questions? Call 1-866-HELLOGP (435-5647) or visit us online at www.gppro.com 2017 Georgia-Pacific Consumer Products LP All rights reserved
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Benzalkonium Chloride 0.1% w/w
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 thoroughly with product and allow to dry without wiping.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, decyl glucoside, PEG-12 Dimethicone, Aloe Barbadensis Leaf Juice, Propylene Gycol, Glycerin, Panthenol Dipotassium Phosphate, Potassium Phosphate
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 To decrease bacteria on skin that could cause disease Recommended for repeated use
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 Benzalkonium Chloride 0.1%w/w WATER DECYL GLUCOSIDE PEG-12 DIMETHICONE ALOE VERA LEAF PROPYLENE GLYCOL GLYCERIN PANTHENOL DIBASIC POTASSIUM PHOSPHATE POTASSIUM PHOSPHATE, UNSPECIFIED FORM 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 Foam Hand Sanitizer with Moisturizers Alcohol Free 1000 mL (33.8 FL OZ) 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 enMotion Foam Hand Sanitizer with Moisturizers Alcohol Free Fregrance Free SKU 42338
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, seek medical attention or call a poison control center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Discontinue use If irritation or redness develops. If condition persists for more than 72 hours, consult a pysician
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 eyes
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