ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:

■ OTC Drug Establishment Registration

■ Drug Product Listing

■ New Drug Application (NDA)

■ U.S. Agent Service

■ Label Review

■ Label Design

Sunscreens, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Skin Protectants, and Topical Analgesics are among more than 300,000 Over-the-Counter (OTC) drug products that are marketed in the U.S. without the need for FDA pre-approval.

OTC drug products are available to consumers without a doctor’s prescription.

A cosmetic product manufactured according to an FDA Monograph.

Monographs define the safety, effectiveness, and labeling of all active ingredients.

All OTC cosmetic products must include standard “Drug Facts” information on the back and/or side of the container.

A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required when a product does not conform to a final monograph.

Of 16 currently marketed active ingredients
2 ingredients, Zinc Oxide and Titanium Dioxide, are generally recognized as safe and effective (GRASE) and not misbranded for use in sunscreens
2 ingredients, PABA and Trolamine Salicylate, are not GRASE for use in sunscreens due to safety issues
12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time
dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2021). This new fee is additional and required. Manufacturers of hand sanitizers and alcohol wipes are currently exempt.

All Drug Establishments must renew their registration between October 1 and December 31, 2021.