Active Ingredient
Alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 60604-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebom Co., Ltd. for the product Hand Sanitizer (NDC 60604-010). 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, purpose, use, do not use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Hand Sanitizer to help decrease bacteria on the skin. For use when soap and water are not available.
Do Not Use
■ In children less than 2 months of age
■ on open skin wounds
Warnings
For external use only. Flammable. Keep away from heat or flame.
When Using This Product
Keep out of eyes ears an mouth . In case of eye contact immediately flush eyes throughly with water
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
In case of accidental ingestion, contact a doctor or Poison Control Center immediately.
Directions
■ Place enough product on your hands to cover all surfaces. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to aviod swallowing.
Other Information
■ Store between 15°-30°C (59°-89°F) ■ Avoid freezing and excessive heat above 40°C (140°F) ■ May discolor fabrics or surfaces
Inactive Ingredients
carbomer, glycerin, triethanolamine, water
Package Label
Package Label (500mlhndsntzrlblrebom)
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