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Product NDC Code | 63354-909 | ||||
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Drug Name | Wet ones antibacterial non plastic hand wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 1038741 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Edgewell Personal Care Brands LLC | ||||
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 For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Alcohol Denat., Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, Lauryl Glucoside, Citric Acid, Ethylhexylglycerin, Tetrasodium EDTA, Fragrance, Aloe Barbadensis Leaf Extract.
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 Medicated skin cleanser • For personal hand hygiene to help prevent the spread of bacteria
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial Agent
Spl product data elements
Usually a list of ingredients in a drug product.Wet Ones Antibacterial Non Plastic Hand Wipes Benzalkonium Chloride CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL ALOE VERA LEAF DEHYDRATED ALCOHOL WATER PROPYLENE GLYCOL BENZALKONIUM CHLORIDE BENZALKONIUM LAURYL GLUCOSIDE
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 Tough on Germs Gentle on Skin Wet Ones ANTIBACTERIAL NON PLASTIC HAND WIPES Plant Based Fibers KILLS 99.99% OF GERMS Hypoallergenic 20 wipes Do Not Flush label
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.Stop use and ask a doctor if irritation develops.
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, call a poison control center or get medical help right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-938-1117
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. If contact occurs, rinse 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 When using this product avoid contact with eyes. If contact occurs, rinse with water Stop use and ask a doctor if irritation develops. Keep out of reach of children If swallowed, call a poison control center or get medical help 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