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| Product NDC Code | 81079-001 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 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 | SHAOXING ELITE BIO-TECH CO.,LTD. | ||||||||||||||
| 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 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 the packet and 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, Vitamin E, Aloe Barbadensis Leaf Juice, 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.Antibacterial Wipes BENZALKONIUM CHLORIDE ALOE VERA LEAF .ALPHA.-TOCOPHEROL PROPYLENE GLYCOL N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) DECYL GLUCOSIDE WATER EDETATE DISODIUM BENZALKONIUM CHLORIDE BENZALKONIUM
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.Antibacterial Wipes Package Label NDC:81079-001-01 NDC:81079-001-02 NDC:81079-001-03 NDC:81079-001-04 NDC:81079-001-05 NDC:81079-001-06 10 20 40 60 80 100
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 unless under adult supervision. 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.Discontinue use and contact a doctor if irritation and redness develop and condition persists 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.When using this product, avoid contact with eyes and mouth. lf product gets in the eyes, flush 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. Consult a doctor prior to 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