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| Product NDC Code | 52862-613 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Health smart antibacterial wet wipes |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CLOTH | ||||||
| RxCUI drug identifier | 1038558 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | International Wholesale, Inc. | ||||||
| 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 Do not expose to direct sunlight, preferably place them in a cool place. Do not use on furniture. Do not flush down toilets, dispose in trash receptacles. Remove lid and open the seal. Pull up the corner of the center sheet, twist it and thread through the dispenser split in the lid.Pull sheet out at an angle. When finished close lid flap to retain moisture.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aqua, Phenoxyethanol, Propylene Glycol, Polysorbate 20, Glycerin, PEG-7 Glyceryl Cocoate, Cocamidopropyl Betaine, Parfum, Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Aloe Barbadensis Leaf Extract (Aloevera), Disodium EDTA, Citric Acid, Citronellol, Hexyl Cinnamal, Limonene, Linalool.
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 decreases bacteria on skin.
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.Health Smart Antibacterial Wet Wipes BENZALKONIUM CHLORIDE WATER PHENOXYETHANOL PROPYLENE GLYCOL POLYSORBATE 20 GLYCERIN PEG-7 GLYCERYL COCOATE COCAMIDOPROPYL BETAINE .ALPHA.-TOCOPHEROL ACETATE ETHYLHEXYLGLYCERIN ALOE VERA LEAF EDETATE DISODIUM ANHYDROUS CITRIC ACID MONOHYDRATE .BETA.-CITRONELLOL, (R)- .ALPHA.-HEXYLCINNAMALDEHYDE LIMONENE, (+)- LINALOOL, (+/-)- 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:50count Label
Package Labeling:100count Label2
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
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: Over large areas of the body if you are allergic to any of the ingredients.
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. For children under 2 years ask a doctor before use. For children use under adult supervision.
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 or rash develops and continues for more than 72 hours.
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 do not get into eyes. If contact occurs, rinse thoroughly with water.
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: Over large areas of the body if you are allergic to any of the ingredients. When using this product do not get into eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours. Keep out of reach of children. For children under 2 years ask a doctor before use. For children use under adult supervision.
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