Active Ingredient
Ethyl Alcohol 75% v/v
Rolhei 75 Percent Ethanol Wet Wipe
FDA Label NDC 78580-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glory Co., Ltd. for the product Rolhei 75 Percent Ethanol Wet Wipe (NDC 78580-010). 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, Cetylpyridinium chloride, Glycerin, Polysorbate, Caprylhydroxamic acid, Citric acid
Purpose
ANTISEPTIC
Warnings
For external use only. Flammable. Keep away from heat or flame
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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 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 irritation or rash occurs. These may be signs of a serious condition.
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.
