Active Ingredient
Benzalkonium Chloride 0.14%
Clean Disinfectant Wipes
FDA Label NDC 78506-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clean One Co., Ltd. for the product Clean Disinfectant Wipes (NDC 78506-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Water, Citric Acid
Purpose
Antiseptic
Warnings
For external use only.
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Do not use
■ in children less than 2 months of age
■ on open skin wounds
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When using this product
■ avoid getting into the eyes (if contact occurs, wash well with clean water)
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Stop use and ask a doctor
■ hypersensitivity symptoms such as erythema, itching and dermatitis happen
■ skin irritation happens
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.
Directions
■ Wet hands thoroughly with product and allow to dry without wiping
■ Do not flush
■ Children under 2 years ask a doctor before use
Other Information
■ Read the directions and warnings before use
■ Store between 15-30℃(59-89℉)
■ Avoid freezing and excessive heat above 40℃(104 ℉)
* Please review the disclaimer below.
