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Product NDC Code | 65601-709 | ||||||||
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Drug Name | Antibacterial foaming skin cleanser |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SOAP | ||||||||
RxCUI drug identifier | 1046593 | ||||||||
Application Number | 505G(a)(3) | ||||||||
Labeler Name | Betco Corporation, Ltd. | ||||||||
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 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, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.
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 skin cleanser. Use in a variety of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
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 Foaming Skin Cleanser Benzalkonium Chloride GERANIOL 2-TERT-BUTYLCYCLOHEXYLOXYBUTANOL DIHYDROMYRCENOL TETRASODIUM GLUTAMATE DIACETATE ANHYDROUS CITRIC ACID ALLYL HEPTANOATE FD&C YELLOW NO. 5 WATER GLYCERIN MAGNESIUM NITRATE ALCOHOL ALOE VERA LEAF METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C RED NO. 40 BENZALKONIUM CHLORIDE BENZALKONIUM COCAMIDOPROPYLAMINE OXIDE LINALOOL, (+/-)- 2-TERT-BUTYLCYCLOHEXYL ACETATE CITRAL N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) HYDROGEN PEROXIDE LIMONENE, (+)-
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.04 55 29
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
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, rinse thoroughly with water. 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