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Product NDC Code | 78506-010 | ||||||||
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Drug Name | Clean disinfectant wipes |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LIQUID | ||||||||
Application Number | part333E | ||||||||
Labeler Name | Clean One Co., Ltd. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Benzalkonium Chloride 0.14%
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 ■ Wet hands thoroughly with product and allow to dry without wiping ■ Do not flush ■ Children under 2 years ask a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Citric Acid
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.Uses Hand sanitizing wipes to help reduce bacteria that potentially can 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.Clean Disinfectant Wipes BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER CITRIC ACID MONOHYDRATE
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: Clean Disinfectant Wipes (55g, 10wipes) Image of container
Package Label: Clean Disinfectant Wipes (110g, 20wipes) Image of container
Package Label: Clean Disinfectant Wipes (460g, 80wipes) Image of container
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ Read the directions and warnings before use ■ Store between 15-30℃(59-89℉) ■ Avoid freezing and excessive heat above 40℃(104 ℉)
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 ■ in children less than 2 months of age ■ on open skin wounds -------------------------------------------------------------------------------------------------------- When using this product ■ avoid getting into the eyes (if contact occurs, wash well with clean water) -------------------------------------------------------------------------------------------------------- Stop use and ask a doctor ■ hypersensitivity symptoms such as erythema, itching and dermatitis happen ■ skin irritation happens
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