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| Product NDC Code | 65601-708 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antibacterial 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 | Betco Corporation, Ltd. | ||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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. Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands. Rinse with clean water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Sodium Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol, 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, physicians 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.Antibacterial Skin Cleanser Chloroxylenol SODIUM CHLORIDE ALCOHOL D&C GREEN NO. 5 FD&C YELLOW NO. 5 MAGNESIUM NITRATE DIMETHYL BENZYL CARBINYL BUTYRATE ETHYL BUTYRATE SODIUM FERROCYANIDE ETHYL ACETOACETATE LAURIC ISOPROPANOLAMIDE SODIUM CARBONATE GLYCOL DISTEARATE .GAMMA.-DECALACTONE METHYLISOTHIAZOLINONE ETHYL METHYLPHENYLGLYCIDATE CHLOROACETIC ACID IONONE BENZYL BENZOATE MYRCENE SODIUM HYDROXIDE METHYL ANTHRANILATE DIMETHYL BENZYL CARBINYL ACETATE CALCIUM SILICATE CALCIUM CATION SODIUM LAURYL SULFATE METHYLCHLOROISOTHIAZOLINONE METHYL ALCOHOL ETHYLENE OXIDE LINALOOL, (+/-)- DIOXANE TRIBASIC CALCIUM PHOSPHATE SODIUM ALUMINIUM SILICATE WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE PHENOXYETHANOL COCO MONOISOPROPANOLAMIDE PROPYLENE GLYCOL CHLOROXYLENOL CHLOROXYLENOL
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.29 19 10 88 04 55
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.©2017 Betco Corporation 400 Van Camp Road Bowling Green, Ohio 43402 Made In U.S.A. All Rights Reserved. 888-GO BETCO (888-462-3826) | Betco.com
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.Winning Hands Antibacterial 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. Children under the age of 6 should be supervised by an adult when using this product. Discontinue use is 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