Home SPL Set DailyMed SPL v2 SPL SPL Set ID ebdddcec-f5da-51fe-e053-2995a90a6167 Route TOPICAL Published Effective Date 2022-10-25 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Phenoxyethanol (0.162 g) Xanthan Gum (0.1 g) Benzoic Acid (0.08 g) Water (0.06 g) Butylene Glycol (0.024 g) Propanediol (16.4578 mL) Polysorbate 20 (0.46 g) Edetic Acid (0.4 g) Proteoglycan 4 (0.2 g) Fragrance 13576 (0.01 g) Glycerin (0.0002 g) Dehydroacetic Acid (0.002 g) Inactive Ingredients Ascorbic Acid Sodium Hydroxide Hyaluronate Sodium Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-25 Until 2027-09-02 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": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.162", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "ACTIB", "strengthNumerator": "0.08", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "0.06", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "ACTIB", "strengthNumerator": "0.024", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "16.4578", "strengthDenominator": "20", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "ACTIB", "strengthNumerator": "0.46", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "ACTIB", "strengthNumerator": "0.4", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "ACTIB", "strengthNumerator": "0.0002", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROTEOGLYCAN 4", "unii": "M65IE9C8XJ", "classCode": "ACTIB", "strengthNumerator": "0.002", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DEHYDROACETIC ACID", "unii": "2KAG279R6R", "classCode": "ACTIB", "strengthNumerator": "0.014", "strengthDenominator": "20", "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: 2026-02-15T12:01:13.302455 · Updated: 2026-03-14T23:01:19.203951
