Food and Drug Administration Information
Calumet’s white oil facilities are registered with the Food and Drug Administration (FDA) as a Bulk Pharmaceutical Manufacturer and conform to current Good Manufacturing Practices (cGMP) as outlined in the Code of Federal Regulations (21CFR211). Calumet White Petrolatums USP, Petrolatums USP, Ointment Bases, and Mineral Jellies contain less than 20 ppm BHT (butylated hydroxytoluene).
Calumet Mineral Oils USP and Light Mineral Oil NF contain less than 20 ppm dl-alpha tocopherol (Vitamin E).
Calumet USP/NF white mineral oils, USP petrolatums (including ointment base), mineral jellies, and Versagel® products are appropriate for use in cosmetic products in the United States, Canada, Europe, Japan and other countries throughout the world.
The International Cosmetic Ingredient Dictionary (INCI) name for all of our oils is “mineral oil”. The INCI name for all of our petrolatums is “petrolatum”. Contact a Product Support Specialist for the INCI names of our Versagel® products.