Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb905bd0-c600-b8b2-e053-2995a90ad259 Route TOPICAL Published Effective Date 2022-10-21 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Alcohol (3.512 mL) Polyoxyl 40 Hydrogenated Castor Oil (0.04 g) Yeast, Unspecified (0.0345 g) Propylene Glycol (0.0138 g) Arctium Lappa Root (0.00007 g) Allantoin (0.025 g) Powdered Cellulose (0.0006 g) Propylparaben (0.0000002 g) Tocopherol (0.000002 g) Fragrance 13576 (0.005 g) Ethylparaben (0.02 g) Ascorbyl Palmitate (0.0001 g) Water (0.000098 g) Tioxolone (0.0000003 g) Levomenol (6.2503117 mL) Hydroxyethyl Cellulose, Unspecified (0.003 g) Isopropyl Alcohol (0.009 g) Farnesol (0.034 g) Methylparaben (0.0012 g) Panthenol (0.001 g) Phenoxyethanol (0.01 g) Butylparaben (0.0100013 g) Niacinamide (0.000006 g) Riboflavin (0.0000005 g) Citral (0.0002 g) Limonene, (+)- (0.000194 g) Fd&c Yellow No. 5 (0.00419 g) Inactive Ingredients Thiamine Hydrochloride .alpha.-tocopherol Acetate Pyridoxine Hydrochloride Vitamin A Palmitate Sodium Acetate Edetate Disodium Anhydrous Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-21 Until 2027-07-07 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": "3.512", "strengthDenominator": "10", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "ACTIB", "strengthNumerator": "0.04", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "YEAST, UNSPECIFIED", "unii": "3NY3SM6B8U", "classCode": "ACTIB", "strengthNumerator": "0.0345", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "0.0138", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ARCTIUM LAPPA ROOT", "unii": "597E9BI3Z3", "classCode": "ACTIB", "strengthNumerator": "0.00007", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "ACTIB", "strengthNumerator": "0.0006", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "ACTIB", "strengthNumerator": "0.0000002", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "THIAMINE HYDROCHLORIDE", "unii": "M572600E5P", "classCode": "IACT", "strengthNumerator": "0.0006", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "ACTIB", "strengthNumerator": "0.000002", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "0.005", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.02", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "unii": "68Y4CF58BV", "classCode": "IACT", "strengthNumerator": "0.0001", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "VITAMIN A PALMITATE", "unii": "1D1K0N0VVC", "classCode": "IACT", "strengthNumerator": "0.000098", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLPARABEN", "unii": "14255EXE39", "classCode": "ACTIB", "strengthNumerator": "0.0000003", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBYL PALMITATE", "unii": "QN83US2B0N", "classCode": "ACTIB", "strengthNumerator": "0.0001", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "6.2503117", "strengthDenominator": "10", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM ACETATE", "unii": "4550K0SC9B", "classCode": "IACT", "strengthNumerator": "0.003", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TIOXOLONE", "unii": "S0FAJ1R9CD", "classCode": "ACTIB", "strengthNumerator": "0.02", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "ACTIB", "strengthNumerator": "0.009", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "ACTIB", "strengthNumerator": "0.034", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "0.0012", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FARNESOL", "unii": "EB41QIU6JL", "classCode": "ACTIB", "strengthNumerator": "0.001", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "ACTIB", "strengthNumerator": "0.0100013", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "ACTIB", "strengthNumerator": "0.005", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.000006", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "ACTIB", "strengthNumerator": "0.0000005", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "0.0002", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "RIBOFLAVIN", "unii": "TLM2976OFR", "classCode": "ACTIB", "strengthNumerator": "0.000006", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRAL", "unii": "T7EU0O9VPP", "classCode": "ACTIB", "strengthNumerator": "0.000194", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "ACTIB", "strengthNumerator": "0.00419", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "ACTIB", "strengthNumerator": "0.00002", "strengthDenominator": "10", "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: 2026-02-15T12:01:13.300999 · Updated: 2026-03-14T23:01:17.657881