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Product NDC Code | 72528-141 | ||||
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Drug Name | Skin cleanser |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOAP | ||||
RxCUI drug identifier | 1362618 | ||||
Application Number | part333A | ||||
Labeler Name | West Coast Paper Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chloroxylenol 0.375%
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 Read the entire label before using this product Place enough product on your palm to thoroughly cover your hands Rinse with clean water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Cocamidopropyl Betaine, Sodium Lauryl Ether Sulfate, Ethylene Glycol Phenyl Ether, Cocamide MIPA, Ethanol, Gycerin, Propylene Glycol, Glycol Distearate, Fragrance, Sodium Chloride, Methylchloroisothiazolinone, Lauramide MIPA, Sodium Hydroxide, Disodium Cocamido MIPA-Sulfosuccinate, Methylisothiazolinone, D&C Green #5, FD&C Yellow #5.
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 Antibacterial hand cleaner Use in daycare, hospitals, nursing homes, physician offices, dental offices and clinics
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.Skin Cleanser Chloroxylenol METHYLISOTHIAZOLINONE ALCOHOL GLYCERIN COCAMIDOPROPYL BETAINE GLYCOL DISTEARATE FRAGRANCE CLEAN ORC0600327 SODIUM CHLORIDE SODIUM LAURETH SULFATE WATER PHENOXYETHANOL METHYLCHLOROISOTHIAZOLINONE LAURAMIDE SODIUM HYDROXIDE D&C GREEN NO. 5 PROPYLENE GLYCOL FD&C YELLOW NO. 5 CHLOROXYLENOL CHLOROXYLENOL COCAMIDE SUCCINIC ACID
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 Label Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Recent major changes Directions
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 KEEP OUT OF REACH OF CHILDREN
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 Avoid contact with eyes If contact occurs, risne thoroghly with water Discontinue use if irritation or redness develops If irritation persists for more than 72 hours, consult a physician 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