0 Items Login Store Rx Products News About Us Contact Us About Us HILL DERMACEUTICALS, Inc. is a privately-owned pharmaceutical company that develops and manufactures innovative dermatology products for children and adults. We provide unique products that enhance the treatment of difficult-to-treat diseases such as scalp psoriasis, atopic dermatitis/eczema, chronically itchy ears, melasma (of the face) and actinic keratosis (pre-cancerous skin conditions). In the belief that a single undertaking performed well is of more value than multiple undertakings that are inadequately completed, Hill resisted all temptations to broaden its market interests to encompass related medical disciplines and has remained true to its original intent and purpose – to serve the field of dermatologic diseases exclusively, to the very best of its ability. To that end, Hill has remained dedicated to its principles of INTEGRITY, QUALITY and SERVICE in the development and manufacture of DERMAtologic products that make a difference in patients’ lives. Hill has remained true to its core belief in developing topical drug products. Hill product vehicles (also known as product base formulations without any active medication ingredients) contain refined peanut oil which has been shown to keep moisture in the skin, promoting effectiveness of Hill’s prescription products indicated for chronic, dry skin conditions. This has been proven in clinical studies for Derma-Smoothe/FS® (comparing the medication to its vehicle) and is reflected in the acceptance of — and loyalty to — Hill’s products by prescribers and patients alike. For this reason, we have introduced a Consumer Line of skin moisturizers based on our product vehicles. (Visit our Online Store) DEVELOPMENT LANDMARKS We have received multiple new drug approvals (NDAs) for prescription medications in dermatology along with the launch of several OTC and related dermatology products. 1988: Approval for Derma-Smoothe/FS® Fluocinolone Acetonide 0.01% Topical Oil (BODY OIL) for moderate to severe atopic dermatitis in adults. The topical vehicle contains 48% refined peanut oil. 1990: Approval for the first and only corticosteroid shampoo containing oat flour for the treatment of seborrheic dermatitis of the scalp. 1995: Approval for Derma-Smoothe/FS® Fluocinolone Acetonide 0.01% Topical Oil (SCALP OIL) for the treatment of moderate to severe scalp psoriasis. The clinical studies and product approval were based on the unique treatment method : treatment of the entire scalp and the use of a shower cap that is packaged with the product. The topical vehicle contains 48% refined peanut oil. 1999: Hill studied and had the first product approved for moderate to severe atopic dermatitis in pediatric patients ages 6 – 12, Derma-Smoothe/FS® Fluocinolone Acetonide 0.01% Topical Oil (BODY OIL). The topical vehicle contains 48% refined peanut oil. 2001: Derma-Smoothe/FS® Fluocinolone Acetonide 0.01% (BODY OIL) received FDA approval for moderate to severe atopic dermatitis in pediatric patients 2 years and older. The topical vehicle contains 48% refined peanut oil. 2002: First approval for the treatment of melasma of the face containing three active ingredients (Fluocinolone Acetonide, Hydroquinone and Tretinoin)1. This was the first time any drug product combining three active ingredients was approved by FDA. 2005: Approval for DermOtic® Oil Fluocinolone Acetonide 0.01% Ear Drops – the first drug approved for the treatment of chronic eczematous external otitis (chronically itchy ears); approved for adults and pediatric patients 2 years and older. The topical vehicle contains 48% refined peanut oil. 2007: Pediatric approval for Derma-Smoothe/FS® Fluocinolone Acetonide 0.01% (BODY OIL) for the treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older. The topical vehicle contains 48% refined peanut oil. 2015: Approval for a patented product, Tolak (fluorouracil) Cream, 4%, in a moisturizing cream containing refined peanut oil, for the topical treatment of actinic keratosis of the face, ears and/or scalp. Hill has two topical prescription products currently under development. Should the clinical studies prove successful, we will once again introduce major advancements in the treatment of difficult-to-treat dermatologic diseases. The uniqueness of Hill’s formulations is due to its (topical) vehicles which help maintain moisture in the skin. Hill’s vehicles are oils and creams – all of which contain refined peanut oil. The peanut oil is pharmaceutical grade, heat refined and purified. An amino acid analysis conducted by Hill quantifies the levels of peanut protein to less than 0.5 parts per million (ppm) to verify that denaturing is accomplished within each batch of refined oil prior to its use in manufacturing. The amino acid test that Hill conducts on the refined peanut oil consistently falls at or below the threshold of 0.5 ppm. During the development of Derma-Smoothe/FS® for children where the product was tested on peanut-allergic patients, FDA asked Hill to develop a test to be able to ensure that the raw material – refined peanut oil NF – meets the same allergen safety criteria from batch to batch, as that which was tested on peanut-allergic patients in Hill’s clinical studies. For this purpose, Hill developed a proprietary test to detect peanut proteins through an amino acid extraction process that quantifies the level of protein to no more than 0.5 parts per million. This test has been validated by Hill and approved by FDA. The safety of the refined peanut oil vehicle used in Hill’s formulations has also been reported in several published clinical studies. MANUFACTURING Hill manufactures all of its products at a GMP (Good Manufacturing Practices) facility in Sanford, Florida, to ensure product quality. Hill sold this NDA to Galderma in 2002 Store Rx Products News About Us Contact Us 2650 S. Mellonville Avenue Sanford, FL 32773-9311 Monday-Friday, 8:30am-5:00pm EST TOLL FREE 1-800-344-5707 1-407-323-1887 FAX 1-407-649-9213 © 2021 Hill Dermaceuticals, Inc. Privacy Policy | Terms and Conditions | Return Policy | Login