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Cleands® Hand Sanitizer
Drug Facts
Cleands Hand Sanitizer
FDA Label NDC 78264-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Refrimed, S.a. De C.v. for the product Cleands Hand Sanitizer (NDC 78264-101). 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 other, active ingredient, purpose, use, warnings, do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Alcohol 70% v/v
Purpose
Antiseptic
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Keep the product away from sunlight.
Do Not Use
Do not use
• in children less than 2 months of age
• on open skin wounds
When Using This Product
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. If symptoms persist call your doctor.
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.
Directions
Directions
• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive Ingredients
Purified water, Carbomer,Glycerine, Fragrance, Triethanolamine
Other Information
Other information
- Other information • Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Package Label - Principal Display Panel
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