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Product NDC Code | 53329-182 | ||||
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Drug Name | Readybath select |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
RxCUI drug identifier | 1038741, 1038746 |
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Application Number | part333A | ||||
Labeler Name | Medline Industries, LP | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium chloride 0.12%
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 gently pull label tab until package opening is exposed remove cloths one at a time to cleanse body parts in the order of the diagram allow skin to dry dispose of cloth in waste receptacle do not flush cloths in toilet diagram
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water (aqua) , cocamidopropyl PG-dimonium chloride phosphate, glycerin, phenoxyethanol, benzoic acid, dehydroacetic acid, ethylhexylglycerin, disodium EDTA, polysorbate 20, sodium citrate, fragrance, simethicone, aloe barbadensis leaf juice
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 for body cleansing to decrease bacteria on the skin helps kill germs that can cause odor
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.ReadyBath Select Benzalkonium Chloride GLYCERIN PHENOXYETHANOL DEHYDROACETIC ACID COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE BENZOIC ACID ETHYLHEXYLGLYCERIN DIMETHICONE ALOE VERA LEAF SODIUM CITRATE EDETATE DISODIUM POLYSORBATE 20 WATER 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.Package Label Label V1 RH22MSC
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.Manufacturing Information Manufactured by: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials www.medline.com 1-800-MEDLINE (633-5463) REF: MSC095104 V1 RH22MSC
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have deep or puncture wounds animal bites serious burns
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in the eyes
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.
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 the condition persists for more than 72 hours or gets worse
Storage and handling
Information about safe storage and handling of the drug product.Other information avoid excessive heat,protect from freezing washcloth: rayon/polyester
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 Do not use in the eyes Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if irritation and redness develop the condition persists for more than 72 hours or gets worse 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