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| Product NDC Code | 86937-005 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Fresh n soft antibacterial wet wipes |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CLOTH | ||||||||
| RxCUI drug identifier | 1038856 | ||||||||
| Application Number | part333A | ||||||||
| Labeler Name | KARDESLER UCAN YAGLAR SANAYI ANONIM SIRKETI | ||||||||
| 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 Ingredients Benzalkonium Chloride (0.1%)
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 • Gently open resealable label, remove and use wipes as required. Keep label closed to prevent moisture loss. • No need to rinse after usage. Allow skin to dry without wiping. • For adults and children 2 years and over. • Discard properly after use. • Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, phenoxyethanol, propylene glycol, parfum, cocamidopropyl betaine, peg-40 hydrogenated castor oil, benzoic acid, tetrasodium edta, dehydroacetic acid, sodium hydroxide
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.Use Decreases bacteria on the skin that could cause disease
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.FRESH N SOFT ANTIBACTERIAL WET WIPES Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER PHENOXYETHANOL PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE POLYOXYL 40 HYDROGENATED CASTOR OIL BENZOIC ACID EDETATE SODIUM DEHYDROACETIC ACID SODIUM HYDROXIDE
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.Packaging IMAGE
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
DERMATOLOGICALLY TESTED EN 1276 KARDESLER UCAN YAGLAR SANAYI A.S. 1957 MANUFACTURER KARDESLER UÇAN YAGLAR SANAYI A.S. INÖNÜ MAHALLESI GEBZE PLASTIKÇILER OSB MAHALLESI 42.SOKAK NO:1 41400 GEBZE - KOCAELI - TÜRKIYE T +90 ( 0262 ) 751 29 30 www.kardeslerucanyaglar.com [email protected] www.freshnsoft.com FreshnSoft FreshnSoft ISO 22716 Good Manufacturing Practices ISO 9001 Quality Management System EAC Made in Turkey.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information • Store in dry and cool place. • Production date, expiry date and lot number are printed on the pack.
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 as baby wipe. • Do not use if you are allergic to any of the ingredients. • Do not use on open skin wounds. When using this products • Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. • Stop use and ask a doctor if irritation or allergic reaction occurs. • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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