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Hand Sanitizer FDA Registration & Approval

Hand Sanitizer is considered as over the counter drug (OTC) as per US FDA regulation. So manufacturing, import or distribution is permitted only after Hand Sanitizer FDA Registration and Listing. More information about FDA registration and listing detailed below.

Hand Sanitizer FDA Registration and Regulation for import products in the USA Market

Hand Wash / Hand Sanitizer FDA Registration Process

Step I : Manufacturing / Brand Owner Establishment Registration

It is important to note, foreign manufactures must appoint US Agent prior to Registration.

 

  1. Active Drug Ingredients should be in OTC Monograph.
  2. Manufacturing process must comply with cGMP requirements.
  3. DUNS number is a must to initiate the process.

Step 2 : NDC Labeler Code

Labeler Code application has to be made to FDA along with registration. First 5 digit of the labeler code will be issued by FDA.

Step 3 : Label Compliance

It is the responsibility of the manufacturer that Hand Sanitizer / Hand Wash / Hand Gel / Hand Wipe primary information / label must comply with FDA regulation.

Step 4: Drug Listing

All Drug planning to market in USA must list. ( All type of Drugs and Drug pack sizes).

Drugs Labels must be submitted to FDA during the time of Drug Listing.

Hand Sanitizer / Wash / Gel Registration fees and Timeline

Mandatory Services

 

  • US Agent Service + Establishment registration + NDC request = $ 649Ā  [6-10 working days]
  • Drug listing $ 399/Drug [6-10 working days] Change in BRAND, Change in FORMULA is considered as separate drugs)

 

Optional Services

 

  • Label Review $ 650 to $ 950/Drug [ 14-20 working days]
  • Guidance Fees $ 649 – $ 849Ā  Ā (DUNS Validation, Active Ingredient Verification, General Guidance & Application Processing)
  • GMP Implementation Support

What is DUNS number? Is it mandatory for FDA Drug Establishment Registration?

DUNS Number is a unique nine digit identification number for physical locationĀ  for your business, which you are planning to register with FDA. DUNS number is mandatory to proceed with FDA Drug Establishment Registration and listing.

 

DUNS is mandatory for Manufacturer and Brand Owner.

Importing Hand Sanitizer / Hand Wash / Hand Gel from any country what all I should take care?

The following are important and manufacturer must comply.

 

  1. Manufacturer must have registered with FDA and listed each of the OTC drugs ( Hand Sanitizer / Hand Wash / Hand Gel) .
  2. US Importer is only a distributor original manufacturer Registration and listing is sufficient.
  3. Incase the US Importer is also the BRAND OWNER, the Brand Owner also must complete the FDA Registration & Listing.
  4. Make sure the OTC Drug Label complies with FDA guidelines.

What is considered as Hand Wash?

Hand Wash Soaps are regulated by FDA as cosmeticsĀ  but, depending on how they are intended to be used and what active ingredients it may be considered as OTC drugs by FDA.

 

  1. Benzethonium chloride
  2. Benzalkonium chloride
  3. Chloroxylenol

 

Generally all Hand Wash products with above ingredientsĀ  called Antiseptic wash products or called as antibacterial soaps. Such products are used along with water and used.

What is considered as Hand Sanitizers, Hand Gel & Hand Wipes

Hand Sanitizers, Hand Gel & Hand Wipes are commonly made using any of the below type of alcohol or non alcohol based active ingredients as per FDA OTC Monograph.

 

  1. Ethyl Alcohol
  2. Ethanol
  3. Isopropyl alcohol
  4. Benzalkonium chloride

 

Hand Sanitizers are generally applied over the skin directly.

Hand Gel, Hand Wipes & Hand Sanitizer FDA Registration can be completed only after issue of NDC Number from FDA?

First 5 digit of NDC number must be isssued by FDA and remaining 5 digits must be issued by the manufacturer.

How can I verify FDA Registration of my company?

Log on to Drug Establishments Current Registration Site and type your Facility / Establishmnet Name. Click Here>>

 

FDA registration & Listing required for Importer or Distributor?

Not required.

 

Only Manufacturer and Brand Owner required to be registered with FDA. ( No matter which country the manufacturer or brand owner located.

What are the hand sanitizer import requirements to FDA?

As mentioned above the manufacturing facility registration and listing are the important requirements to import hand sanitizer to USA. The second important import requirement is label compliance.