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Product NDC Code | 53329-060 | ||||
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Drug Name | Readybath tpc total perineal care |
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Type | Brand | ||||
Pharm Class | Skin Barrier Activity [PE] | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
Application Number | M016 | ||||
Labeler Name | Medline Industries, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 3.2%
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 Open package as designated Remove cloths and thoroughly cleanse soiled area Apply as needed Dispose of cloth in waste receptacle
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Disodium EDTA, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Simethicone, Sodium Benzoate, Polysorbate 20, Water (Aqua)
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 temporarily protects and helps relieve chapped or cracked skin protects minor skin irritation associated with perineal dermatitis
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Readybath TPC Total Perineal Care Dimethicone WATER POLYSORBATE 20 SODIUM BENZOATE BENZALKONIUM CHLORIDE ALOE VERA LEAF CITRIC ACID MONOHYDRATE DIMETHICONE DIMETHICONE Readybath TPC Dimethicone WATER POLYSORBATE 20 SODIUM BENZOATE BENZALKONIUM CHLORIDE ALOE VERA LEAF CITRIC ACID MONOHYDRATE DIMETHICONE DIMETHICONE Readycleanse Cleansing Wipes Dimethicone BENZALKONIUM CHLORIDE ALOE VERA LEAF CITRIC ACID MONOHYDRATE DIMETHICONE DIMETHICONE WATER POLYSORBATE 20 SODIUM BENZOATE Aloetouch Premium Spunlace Cleansing Cloths Dimethicone WATER POLYSORBATE 20 SODIUM BENZOATE BENZALKONIUM CHLORIDE ALOE VERA LEAF CITRIC ACID MONOHYDRATE DIMETHICONE DIMETHICONE Aloetouch Premium Spunlace Dimethicone ALOE VERA LEAF BENZALKONIUM CHLORIDE CITRIC ACID MONOHYDRATE POLYSORBATE 20 WATER SODIUM BENZOATE DIMETHICONE DIMETHICONE Readyflush XLarge Personal Cleansing Cloths Dimethicone WATER POLYSORBATE 20 SODIUM BENZOATE BENZALKONIUM CHLORIDE ALOE VERA LEAF CITRIC ACID MONOHYDRATE DIMETHICONE DIMETHICONE
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.ACTIVE Package Label 53329-060 Label RD12MSC
DEACTIVATED Package Label 53329-061 Label 602283
DEACTIVATED Package Label 53329-062 Label 602813TL
DEACTIVATED Package Label 53329-063 Label 39503TL
DEACTIVATED Package Label 53329-065 Label RD05MSC
DEACTIVATED Package Label 53329-066 Label 066
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.Other information Protect from freezing, avoid excessive heat Keep lid tightly sealed Not made with Natural Rubber Latex Do not flush Cloth: made of Rayon/Polyester
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 on deep or puncture wounds animal bites serious burns
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 consult 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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid direct contact with eyes
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 on deep or puncture wounds animal bites serious burns When using this product avoid direct contact with eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or consult 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