Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb9244ea-6102-3cbe-e053-2a95a90ab8f6 Route TOPICAL Published Effective Date 2022-10-21 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Propylparaben (0.0000001 g) Allantoin (0.0003 g) Panthenol (0.0125 g) Fd&c Yellow No. 5 (0.0025 g) Propylene Glycol (0.00005 g) Arctium Lappa Root (0.000049 g) Methylparaben (0.00001 g) Tioxolone (0.0069 g) Water (0.000035 g) Alcohol (0.00500065 g) Polyoxyl 40 Hydrogenated Castor Oil (0.01 g) Yeast, Unspecified (3.12515585 mL) Ascorbyl Palmitate (1.756 mL) Riboflavin (0.02 g) Ethylparaben (0.01725 g) Tocopherol (0.005 g) Citral (0.000003 g) Limonene, (+)- (0.00000015 g) Powdered Cellulose (0.000001 g) Isopropyl Alcohol (0.000097 g) Hydroxyethyl Cellulose, Unspecified (0.002095 g) Levomenol (0.0006 g) Farnesol (0.017 g) Fragrance 13576 (0.0015 g) Phenoxyethanol (0.0045 g) Butylparaben (0.0005 g) Niacinamide (0.00000025 g) Inactive Ingredients Thiamine Hydrochloride Pyridoxine Hydrochloride Vitamin A Palmitate Edetate Disodium Anhydrous .alpha.-tocopherol Acetate Sodium Acetate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-21 Until 2027-09-20 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": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "ACTIB", "strengthNumerator": "0.0000001", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "THIAMINE HYDROCHLORIDE", "unii": "M572600E5P", "classCode": "IACT", 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"strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "ACTIB", "strengthNumerator": "0.002095", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "ACTIB", "strengthNumerator": "0.0003", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "0.0006", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "ACTIB", "strengthNumerator": "0.017", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM ACETATE", "unii": "4550K0SC9B", "classCode": "IACT", "strengthNumerator": "0.0015", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "ACTIB", "strengthNumerator": "0.0045", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FARNESOL", "unii": "EB41QIU6JL", "classCode": "ACTIB", "strengthNumerator": "0.0005", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.01", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.000003", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "ACTIB", "strengthNumerator": "0.00000025", "strengthDenominator": "5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "0.0001", "strengthDenominator": "5", "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: 2026-02-15T12:01:13.301678 · Updated: 2026-03-14T23:01:19.203951