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 1991 ----------------------------------------------------------------- Brand Name: ABENOL Source: SMITHKLINE BEECHAM Active Ingredient: ACETAMINOPHEN Comments: SUP (120, 325, 650 MG) RT Date: 91/04/10 ----------------------------------------------------------------- Brand Name: ADVIL Source: WHITEHALL-ROBINS Active Ingredient: IBUPROFEN Comments: TAB (200 MG) ORL; CPL (200 MG) ORL Date: 91/07/19 ----------------------------------------------------------------- Brand Name: CHLOR-TRIPOLON NON-DROWSY Source: SCHERING Active Ingredient: LORATADINE Comments: TAB (10 MG) ORL Date: 91/03/26 ----------------------------------------------------------------- Brand Name: CLARITIN Source: SCHERING Active Ingredient: LORATADINE Comments: NEW INDICATION Date: 91/07/15 ----------------------------------------------------------------- Brand Name: CLARITIN EXTRA Source: SCHERING Active Ingredient: LORATADINE/PSEUDOEPHEDRINE SULFATE Comments: CRT (5/120 MG) ORL Date: 91/09/25 ----------------------------------------------------------------- Brand Name: COLPERMIN Source: TILLOTTS PHARMA Active Ingredient: PEPPERMINT OIL Comments: TAB (187 MG) ORL Date: 91/12/16 ----------------------------------------------------------------- Brand Name: CONTAC 12 HOUR ALLERGY FORMULA Source: JCP Active Ingredient: TERFENADINE Comments: TAB (60 MG) ORL; CHANGE IN PRODUCT NAME Date: 91/04/29 ----------------------------------------------------------------- Brand Name: IMODIUM Source: JANSSEN Active Ingredient: LOPERAMIDE HYDROCHLORIDE Comments: REVISED PRODUCT MONOGRAPH Date: 91/10/03 ----------------------------------------------------------------- Brand Name: MAXENAL Source: MCNEIL Active Ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE Comments: TAB (120 MG) ORL Date: 91/12/16 ----------------------------------------------------------------- Brand Name: MEDIPREN GELCAPS Source: IBUPROFEN Active Ingredient: MCNEIL CONSUMER PRODUCTS Comments: GELCAPS (200 MG) ORAL Date: NEW DOSAGE FORM ----------------------------------------------------------------- Brand Name: NIX DERMAL CREAM 5% Source: BURROUGHS WELLCOME Active Ingredient: PERMETHRIN Comments: NEW DOSAGE FORM, NEW STRENGTH, NEW INDICATION Date: 91/08/28 ----------------------------------------------------------------- Brand Name: OPTION & TERFENADINE TABLETS Source: JCP LABS Active Ingredient: TERFENADINE Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/08/26 ----------------------------------------------------------------- Brand Name: PAPULEX Source: GENDERM Active Ingredient: NIACINAMIDE Comments: GEL (4%) TOP Date: 91/05/17 ----------------------------------------------------------------- Brand Name: SCABENE Source: STIEFEL Active Ingredient: PIPERONYL BUTOXIDE/ALLETHRINS Comments: AEP (5.04/0.63 GM/GM) TOP Date: 91/03/13 ----------------------------------------------------------------- Brand Name: SELDANE Source: MERRELL-DOW Active Ingredient: TERFENADINE Comments: CHANGE IN FORMULATION Date: 91/08/02 ----------------------------------------------------------------- Brand Name: SH-206 SHAMPOO Source: GESCAR Active Ingredient: ACETIC ACID/CAMPHOR/LEMON EXTRACT OIL/SODIUM LAURYL ETHER SULPHATE Comments: LIQ (3.65% / 0.76% / 0.76% / 36.55%) SHP Date: 91/05/14 ----------------------------------------------------------------- Brand Name: VIADENT ANTI-PLAQUE TOOTHPASTE WITH FLUORIDE Source: VIPONT PHARMACEUTICAL Active Ingredient: SANGUINARIA EXTRACT, SODIUM MONOFLUOROPHOSPHATE Comments: NEW DOSAGE FORM, NEW INDICATION, CHANGE IN FORMULATION Date: 91/10/18 -----------------------------------------------------------------