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Product NDC Code | 86815-003 | ||||||||||||||
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Drug Name | Deep fresh antibacterial wet wipes |
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Type | Brand | ||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||
Dosage Form | CLOTH | ||||||||||||||
Application Number | part333A | ||||||||||||||
Labeler Name | AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | ||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Benzalkonium Chloride 0.23% w/w. Purpose: Antibacterial-Antifungal
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 DIRECTIONS Provides practical cleaning without the need of water and soap. It is used for hand cleaning. Open the label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rising required.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Dehydroacetic Acid, Benzoic Acid, Lauryl Glucoside, Glycerin, Propylene Glycol, Etidronate Tetrasodium, Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester, Fatty-Acid Amide Hydrolase 1, Phenoxyethanol, Dicaprylyl Carbonate, Glyceryl Oleate, Polysorbate 20, Sterile distilled water
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 Antibacterial Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial / Antifungal Wet Wipes
Spl product data elements
Usually a list of ingredients in a drug product.DEEP FRESH ANTIBACTERIAL WET WIPES BENZALKONIUM CHLORIDE POLYSORBATE 20 DEHYDROACETIC ACID BENZOIC ACID LAURYL GLUCOSIDE GLYCERIN PROPYLENE GLYCOL WATER BENZALKONIUM CHLORIDE BENZALKONIUM OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER FATTY-ACID AMIDE HYDROLASE 1 PHENOXYETHANOL DICAPRYLYL CARBONATE GLYCERYL OLEATE ETIDRONATE TETRASODIUM
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 100 pcs NDC: 86815-003-01 15 pcs NDC: 86815-003-02 100 pcs 15 pcs 80pcs 500pcs 100pcs 160pcs
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.This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: BENZALKONIUM CHLORIDE (0.23%, weight/weight (w/w) Dehydroacetic Acid Benzoic Acid Lauryl Glucoside Glycerin Propylene Glycol Etidronate Tetrasodium Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester Fatty-Acid Amide Hydrolase 1 Phenoxyethanol Dicaprylyl Carbonate Glyceryl Oleate Polysorbate 20 Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
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 wounds
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.Seek a doctor if redness, swelling, itching, or burning occurs on skin.
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 inhale the vapour or grains of the product if occurs. Do not eat or drink or smoke while using the product. Follow all the instructions to avoid risks on human and environmental health. In case of inhaling: Give fresh air or oxygen. If you feel unwell, consult a doctor. In case of skin contact: This product is produced to contact with the skin. Seek a doctor if redness, swelling, itching, or burning occurs on skin. In case of contact with eyes:If you are wearing contact lenses,remove them immediately.Rinse your eyes with plenty of clean water. In case of swallowing: Rinse mouth. Do not vomiting. If unconscious, never give anything by mouth. If it is vomiting, do not lay it on its back and lay it on its side. Call your local Toxication Center and get medical help.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store the product dry,cool,clean place and keep away from direct sunlight. Keep away from children and pets.
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 Keep away from food and animal feeds. For external use only.
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