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| Product NDC Code | 36800-534 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Topcare antibacterial hand fresh and clean |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1046593 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Topco Associates LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium chloride 0.13% Purpose Antibacterial
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 Use only to refill a Liquid Hand Soap pump bottle. From pump bottle, apply onto wet hands. Lather and rinse thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).
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 helps eliminate bacteria on hands.
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.TopCare Antibacterial Hand Fresh and Clean Benzalkonium chloride LAURAMIDOPROPYLAMINE OXIDE GLYCERIN CETRIMONIUM CHLORIDE SODIUM CHLORIDE COCO MONOETHANOLAMIDE PEG-120 METHYL GLUCOSE DIOLEATE CITRIC ACID MONOHYDRATE FRAGRANCE CLEAN ORC0600327 EDETATE SODIUM SODIUM SULFATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C RED NO. 40 FD&C YELLOW NO. 5 WATER D&C RED NO. 33 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.Principal Display Panel- 50 Oz Principal Display Panel
Principal Display Panel- 56 Oz Image of the label
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, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-423-0139
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 using this product and ask a doctor if irritation or redness develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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 contact with eyes. In case of contac, flush with water. Stop using this product and ask a doctor if irritation or redness develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature.
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 avoid contact with eyes. In case of contac, flush with water. Stop using this product and ask a doctor if irritation or redness develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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