Purpose
Antiseptic, Hand Sanitizer
Hygeia Effect Hand Sanitizer
FDA Label NDC 76605-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pecan Bayou Enterprises, Llc for the product Hygeia Effect Hand Sanitizer (NDC 76605-119). 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 purpose, use, active ingredient(s), 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
Use
Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.
Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
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 the eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.
Stop use and ask a doctor if rash or irritation occurs. These may be signs of a serious condition.
Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor is rash or irritation occurs. This may be a sign of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Dosage & Administration
Place enough on hands to cover all surfaces. Rub hands until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Store between 15-50C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Water, Glycerine USP, Carbomer, TEA
Package Label Principal Display Panel
1080000mL NDC:76605-112-06
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