Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb8e5beb-4452-58c2-e053-2a95a90a66e0 Route TOPICAL Published Effective Date 2022-10-21 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Alcohol (52.5 mL) Niacinamide (0.025 g) Tioxolone (0.25 g) Arctium Lappa Root (0.0225 g) Riboflavin (0.00225 g) Polyoxyl 40 Hydrogenated Castor Oil (0.0025 g) Methylparaben (2 g) Yeast, Unspecified (0.5 g) Fd&c Yellow No. 5 (0.14375 g) Glycerin (0.0015 g) Fragrance 13576 (0.45 g) Water (179.89815 mL) Panthenol (0.05 g) Limonene, (+)- (0.015 g) Allantoin (0.10475 g) Citral (0.00485 g) Propylene Glycol (13 g) Inactive Ingredients Sodium Benzoate Citric Acid Monohydrate Edetate Disodium Anhydrous Pyridoxine Hydrochloride Potassium Sorbate Thiamine Hydrochloride Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-21 Until 2027-09-22 Medication Information Warnings and Precautions Indications and Usage Dosage and Administration Section 50565-1 Section 50570-1 Section 51727-6 Section 51945-4 Section 55105-1 Section 55106-9 Structured Label Content Indications and Usage (34067-9) Dosage and Administration (34068-7) Warnings and Precautions (34071-1) Section 50565-1 (50565-1) Section 50570-1 (50570-1) Section 51727-6 (51727-6) Section 51945-4 (51945-4) Section 55105-1 (55105-1) Section 55106-9 (55106-9) Advanced Ingredient Data [{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "52.5", "strengthDenominator": "250", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TIOXOLONE", "unii": "S0FAJ1R9CD", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ARCTIUM LAPPA ROOT", "unii": "597E9BI3Z3", "classCode": "ACTIB", "strengthNumerator": "0.0225", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.00225", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "RIBOFLAVIN", "unii": "TLM2976OFR", "classCode": "ACTIB", "strengthNumerator": "0.0025", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.025", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "unii": "68Y4CF58BV", "classCode": "IACT", "strengthNumerator": "0.0025", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "YEAST, UNSPECIFIED", "unii": "3NY3SM6B8U", "classCode": "ACTIB", "strengthNumerator": "0.14375", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "ACTIB", "strengthNumerator": "0.0015", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.45", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.00225", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "179.89815", "strengthDenominator": "250", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "THIAMINE HYDROCHLORIDE", "unii": "M572600E5P", "classCode": "IACT", "strengthNumerator": "0.015", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "ACTIB", "strengthNumerator": "0.10475", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRAL", "unii": "T7EU0O9VPP", "classCode": "ACTIB", "strengthNumerator": "0.00485", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "13", "strengthDenominator": "250", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:01:13.300274 · Updated: 2026-03-14T23:01:17.657881
