N O T I C E S O F C O M P L I A N C E NONPRESCRIPTION PRODUCTS FOR HUMAN USE January - December, 1993 ----------------------------------------------------------------- Brand Name: Advil Cold & Sinus Caplets Source: Whitehall-Robins Active Ingredient: Ibuprofen / Pseudoephedrine hydrochloride Comments: TAB (200 / 30 mg) ORL Date: 93-06-21 ----------------------------------------------------------------- Brand Name: Apo-Terfenadine Source: Apotex Active Ingredient: Terfenadine Comments: TAB (60, 120 mg) ORL Date: 93-06-02 ----------------------------------------------------------------- Brand Name: Big V Terfenadine 60 mg Tablets Source: Nordic Merrell Dow Research Active Ingredient: Terfenadine Comments: Change in product name Date: 93-07-29 ----------------------------------------------------------------- Brand Name: Canesten Topical Cream 1% Source: Miles Canada Active Ingredient: Clotrimazole Comments: Provides for over the counter sale of Clotrimazole Date: 93-05-25 ----------------------------------------------------------------- Brand Name: Canesten Topical Solution 1% Source: Miles Canada Active Ingredient: Clotrimazole Comments: Provides for over the counter sale of Clotrimazole Date: 93-05-25 ----------------------------------------------------------------- Brand Name: Canesten Vaginal Cream 1% Source: Miles Canada Active Ingredient: Clotrimazole Comments: Provides for over the counter sale of Clotrimazole Date: 93-05-25 ----------------------------------------------------------------- Brand Name: Canesten Vaginal Tablets 100 mg Source: Miles Canada Active Ingredient: Clotrimazole Comments: Provides for over the counter sale of Clotrimazole Date: 93-05-25 ----------------------------------------------------------------- Brand Name: Co-Advil Caplets Source: Whitehall-Robins Active Ingredient: Ibuprofen / Pseudoephedrine hydrochloride Comments: TAB (200 / 30 mg) ORL Date: 93-06-21 ----------------------------------------------------------------- Brand Name: Colgate Total Toothpaste Source: Colgate-Palmolive Active Ingredient: Sodium fluoride / Triclosan Comments: TPT (0.243 / 0.3 %) BUC Date: 93-07-21 ----------------------------------------------------------------- Brand Name: Dimetapp Cold & Sinus Caplets Source: Whitehall-Robins Active Ingredient: Ibuprofen / Pseudoephedrine hydrochloride Comments: TAB (200 / 30 mg) ORL Date: 93-06-21 ----------------------------------------------------------------- Brand Name: Dristan Sinus Caplets Source: Whitehall-Robins Active Ingredient: Ibuprofen / Pseudoephedrine hydrochloride Comments: TAB (200 / 30 mg) ORL Date: 93-06-21 ----------------------------------------------------------------- Brand Name: Guardian Terfenadine 60 mg Tablets Source: Nordic Merrell Dow Research Active Ingredient: Terfenadine Comments: Change in product name Date: 93-07-29 ----------------------------------------------------------------- Brand Name: Hismanal Suspension, Tablets Source: Janssen Pharmaceutica Active Ingredient: Astemizole Comments: Revised product monograph Date: 93-06-28 ----------------------------------------------------------------- Brand Name: IDA Terfenadine 60 mg Tablets Source: Nordic Merrell Dow Research Active Ingredient: Terfenadine Comments: Change in product name Date: 93-07-29 ----------------------------------------------------------------- Brand Name: Micatin Source: Ortho-McNeil Active Ingredient: Miconazole nitrate Comments: Provides for switch to nonprescription status Date: 93-06-03 ----------------------------------------------------------------- Brand Name: Monistat 7 Vaginal Cream 2% Source: Ortho-McNeil Active Ingredient: Miconazole nitrate Comments: Sale without prescription Date: 93-07-19 ----------------------------------------------------------------- Brand Name: Monistat 7 Vaginal Suppositories 3.8% Source: Ortho-McNeil Active Ingredient: Miconazole nitrate Comments: Sale without prescription Date: 93-07-19 ----------------------------------------------------------------- Brand Name: Motrin IB Tablets Source: UpJohn Active Ingredient: Ibuprofen Comments: Provides for new physicians sample Date: 93-02-16 ----------------------------------------------------------------- Brand Name: Naftin Cream & Gel Source: Allergan Herbert Active Ingredient: Naftifine hydrochloride Comments: CRM (1 %) TOP, GEL (1 %) TOP Date: 93-02-08 ----------------------------------------------------------------- Brand Name: Nicorette Source: Merrell Dow Active Ingredient: Nicotine polacrilex Comments: GUM (2 mg) ORL Date: 93-01-29 ----------------------------------------------------------------- Brand Name: Novo-Terfenadine Source: Novopharm Active Ingredient: Terfenadine Comments: TAB (60 mg) ORL Date: 93-06-03 ----------------------------------------------------------------- Brand Name: PMS-Acetaminophen Suppositories Source: Pharmascience Active Ingredient: Acetaminophen Comments: SUP (120, 160, 325, 650 mg) RT Date: 93-08-12 -----------------------------------------------------------------