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Product NDC Code | 75109-001 | ||||||||||||||||||||||||||||||||||||||||
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Drug Name | Antibacterial wipes |
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Type | Brand | ||||||||||||||||||||||||||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||
Dosage Form | SWAB | ||||||||||||||||||||||||||||||||||||||||
RxCUI drug identifier | 1038558 | ||||||||||||||||||||||||||||||||||||||||
Application Number | part333A | ||||||||||||||||||||||||||||||||||||||||
Labeler Name | Kangna (Zhejiang) Medical Supplies Co., Ltd. | ||||||||||||||||||||||||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium Chloride 0.13% Purpose Antiseptic
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 V notch located on top of plastic bag. Pull first wipe from the center of roll up through opening of bag. ●Thread first wipe through the dispensing nozzle in lid of floor stand OR. Thread first wipe through the dispensing nozzle in top of wall mounted dispenser. Close dispenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients | Water, Polysorbate 20, EDTA 2Na, Phenoxyethanol, 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 ●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Recommended for repeated use. ●Dries in seconds.
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.Antibacterial wipes Benzalkonium Chloride WATER DISODIUM EDTA-COPPER POLYSORBATE 20 PHENOXYETHANOL SODIUM HYDROXIDE 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.1
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.
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.Warning ●For external use only. ●May irritate eyes. ●Keep out of reach of children unless under adult supervision.
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