Active Ingredient
Active Ingredients: Benzalkonium Chloride 0.1%
Pure Fine Mediwiper
FDA Label NDC 76522-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyosung Sp Co.,ltd for the product Pure Fine Mediwiper (NDC 76522-010). 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 ingredient, purpose, keep out of reach of children, uses, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid
Purpose
Purpose: antiseptic
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Uses:
■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease
■ instant hand antiseptic to decrease bacteria on the skin
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame
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Do not use
• in combination with soap or antibacterial cleansing agents
• the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin. It is not recommended to use this one areas that have been medically treated with a cast or bandage
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if hypersensitivity symptoms such as erythema, itching and dermatitis happen or skin irritation happens.
Directions
Directions:
■ Scrub and wipe off the hand and skin, which are used individually or if necessary
■ Clean with wipes and let dry
Other Information
Other information:
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
* Please review the disclaimer below.
