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Product NDC Code | 35000-677 | ||||||
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Drug Name | Softsoap antibacterial kitchen fresh hands |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 1046593, 1367082 |
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Application Number | 505G(a)(3) | ||||||
Labeler Name | COLGATE PALMOLIVE COMPANY | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium chloride 0.13%
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 wash hands and rinse
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, cetrimonium chloride, glycerin, lauramidopropylamine oxide, cocamide MEA, sodium chloride, fragrance, PEG-120 methyl glucose dioleate, citric acid, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow No. 5, D&C red No. 33
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.Use helps eliminate bacteria on hands
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.SoftSoap Antibacterial Kitchen Fresh Hands Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER CETRIMONIUM CHLORIDE GLYCERIN LAURAMIDOPROPYLAMINE OXIDE COCO MONOETHANOLAMIDE SODIUM CHLORIDE PEG-120 METHYL GLUCOSE DIOLEATE CITRIC ACID MONOHYDRATE EDETATE SODIUM METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 D&C RED NO. 33
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 - 332 mL Bottle Label 50% MORE VS 7.5 FL OZ Softsoap ® brand KITCHEN FRESH HANDS ® ANTIBACTERIAL HAND SOAP ODOR NEUTRALIZING UNIQUE FORMULA REFILL ONLY WITH SOFTSOAP ® ANTIBACTERIAL Citrus Extracts 11.25 FL OZ (332 mL) 9912933 PRINCIPAL DISPLAY PANEL - 332 mL Bottle 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
Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022
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, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-255-7552
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. In case of contact, flush 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 When using this product avoid contact with eyes. In case of contact, flush with water. Keep out of reach of children, except under adult supervision. 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