Hand Sanitizer: US FDA Registration and Requirements
U.S. FDA regulates Hand Sanitizer gel, wash and wipes under OTC Drug category. Manufacturers and Brand owners should register and get the approval from the FDA prior selling Hand Sanitizer in the US market.
Hand Sanitizer US FDA registration process
Step 1: FDA Hand Sanitizer Labeling Requirements
Cosmereg reviews ingredients and labeling requirements following OTC monograph requirements and suggest to manufacturers/brand owner of Hand Sanitizer if the product is in line with FDA regulations before proceeding with the Registration.
Step 2. DUNS number request
All manufacturers and brand owners of Hand Santizizer have to request the DUNS number to proceed with the FDA registation and NDC labeler code request.
To request the DUNS number is free of charge please follow this link DUNS webpage
Step 3. Manufacturing and Private Label Distributor/Owner Establishment Registration
After getting the DUNS number Cosmereg registers the manufacturing establishment to the FDA portal. Note all foreign manufacturers must appoint a US Agent, Cosmereg provides this service. In addition Manufacturers of Hand Sanitizer have to comply with the cGMP (current good manufacturing practices).
Step 4. NDC Labeler Code Request
Cosmereg can assist to get the NDC labeler code which is a 5 digits number issued by the FDA necessary to proceed with the Hand Sanitizer Registration.
Step 5. Drug Listing/Registration
At this stage the Hand Sanitizer can be registered to the FDA portal. After the product is submitted and get approved, manufacturers and brand owners can export their products to the US.
The full process can take from 7 to 15 working days.
Cosmereg can assist you in complying with the FDA’s Cosmetic Drug Establishment Registration, request the labeler code and Drug Listing, no matter the specific category.
Phone
+1-727-350-9380
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FAQ
What is a DUNS Number?
The DUNS number is a numeric company identification code necessary to locate your business and to proceed with the establishment registration and NDC labeler code request.
What is NDC Labeler Code
NDC labeler code is a 5 digits identification number assigned by the FDA to manufacturers and Private label distributors/brand owners to register the establishment and drug listing.
Are Over The Counter (OTC) products FDA approved?
OTC drugs are those that can be sold without a prescription from a medical professional. In these cases, the FDA regulates the formulations and labelling of different classes of drug, rather than the individual products. The FDA develops ‘monographs’ with guidelines for their production, distribution and application. Once the monograph is developed, companies can produce and sell these drugs without FDA pre-approval, as long as they are manufactured according to the guidelines. Monographs are used to establish the safety, effectiveness and required labelling of all OTC products.
What is the OTC monograph system?
A ‘monograph’ is used to define the safe and appropriate manufacture and use of OTC drugs. It covers ingredients, doses, formulation, indications for use and how the product should be labelled. Companies can manufacture and sell these drugs without a specific product license, as long as they conform to what is stipulated in the monograph. Monographs are published in the government’s Code of Federal Regulations(CFR). The function of the FDA is to ensure that the obligations of the Federal Food, Drug and Cosmetic Act are fulfilled.
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