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| Product NDC Code | 68599-0214 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antimicrobial |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1049254 | ||||||
| Application Number | M003 | ||||||
| Labeler Name | McKesson | ||||||
| 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 Spray soiled and/or odorous (body and/or perineal) areas Gently wipe clean Repeat as necessary until all soils are removed and skin is clean Pat dry No rinsing necessary Apply a protectant cream or paste as necessary
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alanine, Aloe Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Chlorphenesin, Fragrance, Glutamic Acid, Glycerin, Glycine, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine, Polysorbate 20, Proline, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tetrasodium EDTA, Threonine, Tocopheryl Acetate (Vitamin E), Tyrosine, Valine, Water (may contain Citric Acid, Sodium Hydroxide)
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 a no-rinse topical antiseptic for reducing and inhibiting bacterial growth.
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.Antimicrobial Body Cleanser WATER PROLINE VALINE LEUCINE NIACINAMIDE .ALPHA.-TOCOPHEROL ACETATE LYSINE GLYCERIN POLYSORBATE 20 PHENYLALANINE ARGININE CAPRYLYL GLYCOL CHLORPHENESIN SODIUM ASCORBYL PHOSPHATE OCTENYLSUCCINIC ACID THREONINE GLYCINE EDETATE SODIUM EDETIC ACID HISTIDINE ISOLEUCINE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES CALCIUM PANTOTHENATE MALTODEXTRIN PYRIDOXINE HYDROCHLORIDE ASPARTIC ACID GLUTAMIC ACID ALANINE TYROSINE SERINE BUTYLENE GLYCOL PHENOXYETHANOL SILICON DIOXIDE ALOE VERA LEAF HYALURONATE SODIUM BENZALKONIUM CHLORIDE BENZALKONIUM
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.NDC 68599-0214-4 McKesson Thera ANTIMICROBIAL BODY CLEANSER A no-rinse topical cleanser for reducing and inhibiting bacterial growth. Single Patient Use NET CONTENTS 4 fl. oz (118 mL) MFR # 53-AC4 each
NDC 68599-0214-8 McKesson Thera ANTIMICROBIAL BODY CLEANSER A no-rinse topical cleanser for reducing and inhibiting bacterial growth. Single Patient Use NET CONTENTS 8 fl. oz (237 mL) MFR # 53-AC8 each
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 of children. If swallowed, get medical help or contact a poison control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store at 40-95ºF (4-35ºC)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-777-4908
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 condition persists for more than 72 hours
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 do not get into eyes Do not use on deep or puncture wounds animal bites serious burns
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