OTC Products

OTC Drug Establishment Registration

US FDA OTC Drug Listing Requirements

US FDA OTC Drug Labeling Requirements

FDA Drug Registration Certificate

NDC Labeler code request to FDA

Reviewing and editing labels to comply with FDA requirements

Review product ingredients to comply with FDA requirements
— FDA Approval – Final rule on Antiseptic Hand Sanitizers
— Active Ingredients and label review
— FDA Registration and NDC Number for Hand Sanitizer

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