The following Structured Product Label (SPL) was submitted to the FDA by Branders.com, Inc. for the product Branders Antiseptic Hand Sanitizer (NDC 53017-801). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredientEthyl Alcohol 62%
Otc - Purpose
PurposeAntiseptic
Indications & Usage
UsesFor hand washing to decrease bacteria on the skinRecommended for repeated useFlammable. Keep away from heat and flame.
Warnings
WarningsFor external use only.
Otc - When Using
When using this productDo not use in or near the eyes. In case of contact, rinse eyes
thoroughly with water. Avoid contact with broken skin.
Otc - Stop Use
Discontinue Useif irritation and redness develops. If condition persists for
more than 72 hours consult a doctor.
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
DirectionsWet hands thoroughly with product and allow to dry without
wipingChildren under 6 of age should be supervised when using this product.Not recommended for infants.Other InformationDo not store above 105 degrees F.May discolor some fabrics.
Inactive Ingredient
Inactive IngredientsWater, glycerin, propylene glycol, aloe, fragrance
* Please review the disclaimer below.