Home SPL Set DailyMed SPL v2 SPL SPL Set ID eca95dde-cb57-2ab6-e053-2995a90af84f Route TOPICAL Published Effective Date 2022-11-04 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Glycolic Acid (17 g) Kojic Acid (2.5 g) Hexylresorcinol (1 g) Ascorbyl Glucoside (0.25 g) Lactic Acid (5 g) Phenoxyethanol (0.225 g) Propylene Glycol (0.5 g) Hydroxyethyl Cellulose, Unspecified (0.34875 g) Alcohol (6.3 mL) Ammonia (2.75 g) Isopropyl Alcohol (0.75 g) Water (0.01875 g) Ethylhexylglycerin (7.333 mL) Salicylic Acid (0.025 g) Inactive Ingredients Citric Acid Monohydrate Nitrate Ion Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-11-04 Until 2027-07-01 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": "GLYCOLIC ACID", "unii": "0WT12SX38S", "classCode": "ACTIB", "strengthNumerator": "17", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "KOJIC ACID", "unii": "6K23F1TT52", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HEXYLRESORCINOL", "unii": "R9QTB5E82N", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBYL GLUCOSIDE", "unii": "2V52R0NHXW", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LACTIC ACID", "unii": "33X04XA5AT", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.225", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "ACTIB", "strengthNumerator": "0.34875", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "6.3", "strengthDenominator": "50", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "ACTIB", "strengthNumerator": "2.75", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "0.75", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "NITRATE ION", "unii": "T93E9Y2844", "classCode": "IACT", "strengthNumerator": "0.01875", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "7.333", "strengthDenominator": "50", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "50", "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: 2026-02-15T12:01:13.316383 · Updated: 2026-03-14T23:01:19.203951
