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Product NDC Code | 11084-813 | ||||||
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Drug Name | Soft n sure foamed antiseptic handrub |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | AEROSOL, FOAM | ||||||
RxCUI drug identifier | 616763 | ||||||
Application Number | part333E | ||||||
Labeler Name | SC Johnson Professional USA, Inc. | ||||||
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 Healthcare Personnel Handwash Apply product to hands and rub until thoroughly dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Water), Emulsifying Wax, Hydrofluorocarbon 152A, Isobutane, Propane.
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 Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.
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.Soft N Sure Foamed Antiseptic Handrub Alcohol ALCOHOL ALCOHOL WATER 1,1-DIFLUOROETHANE ISOBUTANE PROPANE
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 - 255 g Can Label SCJ PROFESSIONAL HEALTHCARE Soft 'N Sure ® NDC 11084-813-36 Hand Sanitizer Foamed Antiseptic Handrub Moisturization 15 seconds Fast Acting CHG Compatible Net Weight: 255 g (9 oz) SAP # 4000000054 Manufactured for: SC Johnson Professional USA, Inc. Charlotte, NC 28217 1-866-783-0422 www.scjp.com Pat. www.scjp.com/patents REORDER # 1381-36 deb SKIN CARE PRINCIPAL DISPLAY PANEL - 255 g Can Label
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
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 children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-783-0422
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 irritation and redness develop. If irritation persists for more than 3 days, consult a physician.
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 avoid contact with eyes. If splashed in eyes, rinse promptly and thoroughly with water do not puncture or incinerate; contents under pressure.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not store above 120°F (49°C). For best foam density store and use at 55 - 85°F (13 - 29°C).
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. When using this product avoid contact with eyes. If splashed in eyes, rinse promptly and thoroughly with water do not puncture or incinerate; contents under pressure. Stop use and ask a doctor if irritation and redness develop. If irritation persists for more than 3 days, consult a physician. Keep out of reach children. In case of accidental ingestion, seek professional assistance or contact a Poison Control 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