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Product NDC Code | 50021-007 | ||||||
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Drug Name | Foam hand sanitizer |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | AEROSOL, FOAM | ||||||
RxCUI drug identifier | 616805 | ||||||
Application Number | part333A | ||||||
Labeler Name | Empack Spraytech Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (v/v ) Ethyl Alcohol 70%
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 Aloe Barbadensis Leaf Juice, Aqua, Bis-PEG-12 Dimethicone, Ceteareth-25, Glycerin, Isobutane, Stearyl alcohol.
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 reduces bacteria that potentially can cause disease. Recommended for repeated use. 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.Foam Hand Sanitizer Alcohol 70% ALCOHOL ALCOHOL GLYCERIN WATER CETEARETH-25 STEARYL ALCOHOL BIS-PEG-12 DIMETHICONE (70 MPA.S) ALOE VERA LEAF ISOBUTANE
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 - Foaming Hand Sanitizer Foaming Hand Sanitizer Alcohol Antiseptic 70% Optional size ranges between 100g to 325g Principal display panel - Foaming H Sanitizer
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 children less than 2 months 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at room temperature 15-30 C (59-86°F). May stain surfaces and fabrics. Avoid freezing and extrensive heat avbove 40C (104F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? 1-866-923-2665 Manufactured in Canada by Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6 UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal
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 if rash occurs.
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 keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water
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 fire or flame Do not use in children less than 2 months age on open skin wounds Stop use and ask a doctor if rash occurs. When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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