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| Product NDC Code | 78564-006 | ||||
|---|---|---|---|---|---|
| Drug Name | Wet wipes ten |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1038558 | ||||
| Application Number | part333A | ||||
| Labeler Name | TAHA KIMYA KOZMETIK VE TUKETIM URUNLERI SANAYI PAZARLAMA ANONIM SIRKETI | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium Chloride 0.13% w/w. Purpose: Antibacteria
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 Peel back flap on front to pull out a wipe. Unfold and wipe hands thoroughly. Reseal and let hands dry. No need to rinse.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, phenoxyethanol, propylene glycol, polysorbate 20, peg-7 glyceryl cocoate, cocamidopropyl betaine, parfum, tocopheryl acetate, ethylhexylglycerin, aloe barbadensis leaf extract, 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.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 conrer 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.
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.Wet wipes Ten Benzalkonium Chloride EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE .BETA.-CITRONELLOL, (R)- GLYCERIN PEG-7 GLYCERYL COCOATE ETHYLHEXYLGLYCERIN CITRIC ACID MONOHYDRATE POLYSORBATE 20 COCAMIDOPROPYL BETAINE ALOE VERA LEAF .ALPHA.-HEXYLCINNAMALDEHYDE LIMONENE, (+)- WATER BENZALKONIUM CHLORIDE BENZALKONIUM PROPYLENE GLYCOL LINALOOL, (+/-)- PHENOXYETHANOL
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 label. Principal display panel 2
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 children less than 2 months of age on open skin
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 contact 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 irritation or rash occurs. These may be signs of a serious condition.
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.decreases bacteria on skin
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15-30℃ (59-86℉)
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. Flammable. Keep away from heat or flame Do not replace wipes used for medical procedures. These wipes are meant for general cleansing.
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