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Antibacterial bathing - Medication Information

Product NDC Code 63517-210
Drug Name

Antibacterial bathing

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 1038558
Application Number M003
Labeler Name Cardinal Health, Inc.
Packages
Package NDC Code Description
63517-210-22 8 pouch in 1 packet (63517-210-22) / 1 patch in 1 pouch / 13.775 ml in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Benzalkonium Chloride 0.13% Purpose Antiseptic

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 Cloths can be used at room temperature or heated in a wipes warmer for extra comfort. Warming Instructions: single warming session at temperatures not to exceed 52˚C (125˚F) and for a maximum of 200 hours. Discard wipes that have been exposed to warming temperatures exceeding 52˚C (125˚F) or stored longer than 200 hours in the warmer. Bathing Instructions: Remove one cloth at a time to clean each area in the following order: 1. Neck & facial area; 2. Front torso; 3. Right arm; 4. Left arm; 5. Right leg; 6. Left leg; 7. Back torso; 8. Buttocks & perineal area Allow skin to dry Dispose of cloth in waste receptacle Do not flush cloths in toilet

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aqua, Phenoxyethanol, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Myristamidopropyl PG-Dimonium Chloride Phosphate, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citric Acid, Disodium EDTA, Allantoin.

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 to decrease bacteria on skin

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.
Antibacterial Bathing BENZALKONIUM CHLORIDE WATER PHENOXYETHANOL SODIUM BENZOATE ALOE VERA LEAF MYRISTAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS ALLANTOIN 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 Labeling: Label

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

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 you use if you have: Deep 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 eye Longer than 1 week unless directed by a physician Over raw surfaces or blistered areas

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. In case of accidental ingestion seek medical help or contact a Poison Control Center immediately. Gloves diminish sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals

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 heat sealed package in microwave Ask a doctor before you use if you have: Deep puncture wounds Animal bites Serious burns Keep out of reach of children. In case of accidental ingestion seek medical help or contact a Poison Control Center immediately. Gloves diminish sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals Do not use In the eye Longer than 1 week unless directed by a physician Over raw surfaces or blistered areas

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