Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb53cba1-0509-43bc-e053-2995a90a5e09 Route TOPICAL Published Effective Date 2022-10-18 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Glycerin (0.01035 g) Phenoxyethanol (0.0003 g) Fragrance 13576 (0.00285 g) Dehydroacetic Acid (0.00135 g) Water (0.00015 g) Peg-8 Caprylic/capric Glycerides (0.000105 g) Isomethyl-.alpha.-ionone (1.16659425 mL) Edetic Acid (0.000009 g) Benzoic Acid (0.00003 g) Sorbic Acid (0.15 g) Benzyl Alcohol (0.0009 g) Propanediol (0.0006 g) Hydroxycitronellal (0.0045 g) Inactive Ingredients Dipeptide Diaminobutyroyl Benzylamide Salicylic Acid Sodium Benzoate Food Yellow 3 Free Acid Potassium Sorbate Ascorbic Acid Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-18 Until 2027-01-13 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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.01035", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.0003", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.00285", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DEHYDROACETIC ACID", "unii": "2KAG279R6R", "classCode": "ACTIB", "strengthNumerator": "0.00135", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE", "unii": "O0FY926GMK", "classCode": "IACT", "strengthNumerator": "0.00015", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "IACT", "strengthNumerator": "0.000105", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "1.16659425", "strengthDenominator": "1.5", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.000009", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FOOD YELLOW 3 FREE ACID", "unii": "G2B7JWK1GG", "classCode": "IACT", "strengthNumerator": "0.00003", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PEG-8 CAPRYLIC/CAPRIC GLYCERIDES", "unii": "00BT03FSO2", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOMETHYL-.ALPHA.-IONONE", "unii": "9XP4LC555B", "classCode": "ACTIB", "strengthNumerator": "0.00003", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "ACTIB", "strengthNumerator": "0.000009", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "ACTIB", "strengthNumerator": "0.0009", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "ACTIB", "strengthNumerator": "0.0006", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.000009", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "0.0045", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "ACTIB", "strengthNumerator": "0.01215", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "1.5", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYCITRONELLAL", "unii": "8SQ0VA4YUR", "classCode": "ACTIB", "strengthNumerator": "0.00006", "strengthDenominator": "1.5", "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: 2026-02-15T12:01:13.297714 · Updated: 2026-03-14T23:01:17.657881
