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| Product NDC Code | 77267-003 | ||||||||||||||||||||||||||||||
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| Drug Name | Hand antibacterial 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 | NingboRiwayIndustrialCo.,Ltd. | ||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Benzalkonium Chloride 0.13%
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 Tear open packet, remove wipe. Wet hands thoroughly with product and let hands air dry. Throw used wipe in trash. Do not flush.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Aqua.
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 skin.
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.Hand Antibacterial Wipes BENZALKONIUM CHLORIDE N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) DECYL GLUCOSIDE WATER BENZALKONIUM CHLORIDE BENZALKONIUM PROPYLENE GLYCOL EDETATE DISODIUM
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.Hand Antibacterial Wipes Package Label 40 g in 1 Bag(10 Wipes),NDC:77267-003-05 353 g in 1 Bag(80 Wipes),NDC:77267-003-06 538 g in 1 Pail(160 Wipes),NDC:77267-003-03 1368 g in 1 Pail(500 Wipes),NDC:77267-003-04 36 g in 1 Bag(10 Wipes),NDC:77267-003-07 36 g in 1 Bag(10 Wipes),NDC:77267-003-08 2700 g in 1 Bag(1000 Wipes),NDC:77267-003-09 538 g in 1 Pail(160 Wipes),NDC:77267-003-10 1368 g in 1 Pail(500 Wipes),NDC:77267-003-11 1800 g in 1 Pail(500 Wipes),NDC:77267-003-12 label 10 label 80 label 160 label 500 label-10-JW-2 label-10-PB-2 1000pcs Hand Antibacterial Wipes Purigen Hand Sanitizing Wipes 160 wipes Purigen Hand Sanitizing Wipes 500 wipes label-500 15x20cm
Hand sanitizing wipes package label 96g in 1 Bag(25 wipes), NDC:77267-003-13 4g in 1 Pouch(1 wipe), NDC:77267-003-14 Inner bag 25pcs 165x115x140 for 6 pouch 165x185x140 for 10 pouch 165x290x140mm for 16 pouch 120 inner pouch 1 23x8.2x12.3cm outer packing box 120pcs
Allure All-Purpose Wipes Package Label NDC:77267-003-15 Allure All-Purpose Wipes
Multi-purpose Disinfecting Wipes Disinfecting Wipes Tub Die Cut new
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 Do not use 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. 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 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.Using this product do not get into eyes. lf contact occurs, rinse thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping. Children under 2 years. Ask a doctor before use.
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.
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