Drug Facts Panel - Active Ingredients
Denatured Ethyl Alcohol 70% v/v. Purpose: Antiseptic.
Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-sterile Gel
FDA Label NDC 79916-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Be Factory Laboratories Industria Comercio Importacao E Exportacao Ltda for the product Clean Sept Alcohol Antiseptic 70% - Topical Hand Sanitizer Non-sterile Gel (NDC 79916-001). 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 drug facts panel - active ingredients, drug facts panel - purpose, drug facts panel - use, drug facts panel - warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Drug Facts Panel - Purpose
Purpose: Antiseptic.
Drug Facts Panel - Use
Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Drug Facts Panel - Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
● in children less than 2 months of age
● on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly 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. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use
● in children less than 2 months of age
● on open skin wounds
Otc - When Using
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.
Otc - 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.
Drug Facts Panel - 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.
Drug Facts Panel - Other Information
Store between 15-30 °C (59-86 °F)
Avoid freezing and excessive heat above 40 °C (104 °F)
Drug Facts Panel - Inactive Ingredients
Carbomer, Glycerin, Triethanolamine, Water.
Package Label - Principal Display Panel
200 ml, NDC 79916-001-01
500 ml, NDC 79916-001-02
1500 ml, NDC 79916-001-03
5000 ml, NDC 79916-001-04
3 ml, NDC 79916-001-05
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