Other
This is a gel hand sanitizer manufactured using only United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.
Covigel
FDA Label NDC 74593-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Flavorcraft Industries Inc for the product Covigel (NDC 74593-003). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Alcohol 80% v/v.
Otc - Purpose
Purpose: Antiseptic
Indications & Usage
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.
Otc - 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 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.
Dosage & Administration
• 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.
Storage And Handling
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
purified water USP, glycerin, hydroxyethyl cellulose, sodium hydroxide, fragrance.
Package Label.Principal Display Panel
3785mL NDC: 74593-003-28
200mL NDC: 74593-003-06
1.25mL NDC: 74593-003-01
236mL NDC: 74593-003-08
18925mL NDC: 74593-003-05
208175mL NDC: 74593-003-55
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