Home SPL Set DailyMed SPL v2 SPL SPL Set ID f2274f8c-08aa-eb02-e053-2a95a90a3998 Route TOPICAL Published Effective Date 2023-01-13 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Aloe Vera Leaf (0.042 g) Linalool, (+/-)- (0.012 g) Eugenol (5.988 g) Propanediol (0.0018 g) Benzyl Alcohol (0.054 g) Cetostearyl Alcohol (0.0006 g) Dicaprylyl Ether (2.496 g) Sorbic Acid (0.456 g) Xanthan Gum (1.2 g) .beta.-citronellol, (r)- (1.5 g) Glyceryl Monostearate (0.024 g) Fragrance 13576 (0.18 g) Salicylic Acid (2.4 g) Jujube Seed (0.114 g) Lecithin, Soybean (0.09 g) Baicalin (0.048 g) Leuzea Carthamoides Root (0.036 g) Water (33.2616 mL) Limonene, (+)- (0.006 g) Hydroxycitronellal (0.0024 g) Tocopherol (3.036 g) Glycerin (3.9 g) Decyl Oleate (3 g) Shea Butter (2.1 g) Inactive Ingredients Sodium Hydroxide Potassium Sorbate Citric Acid Monohydrate Phytate Sodium Hydrogenated Palm Glycerides Citrate Deanol Sodium Benzoate Hyaluronate Sodium Glyceryl Stearate Citrate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2023-01-13 Until 2028-03-06 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": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "0.042", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.012", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "ACTIB", "strengthNumerator": "5.988", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.0018", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHYTATE SODIUM", "unii": "88496G1ERL", "classCode": "IACT", "strengthNumerator": "0.054", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "ACTIB", "strengthNumerator": "0.0006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EUGENOL", "unii": "3T8H1794QW", "classCode": "ACTIB", "strengthNumerator": "0.0006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "ACTIB", "strengthNumerator": "2.496", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "ACTIB", "strengthNumerator": "0.456", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "ACTIB", "strengthNumerator": "1.2", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DICAPRYLYL ETHER", "unii": "77JZM5516Z", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "ACTIB", "strengthNumerator": "0.024", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "ACTIB", "strengthNumerator": "0.18", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".BETA.-CITRONELLOL, (R)-", "unii": "P01OUT964K", "classCode": "ACTIB", "strengthNumerator": "0.0006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROGENATED PALM GLYCERIDES CITRATE", "unii": "23AS6RA25L", "classCode": "IACT", "strengthNumerator": "0.0006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "ACTIB", "strengthNumerator": "2.4", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.114", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.09", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "JUJUBE SEED", "unii": "I51YGQ1Q2L", "classCode": "ACTIB", "strengthNumerator": "0.048", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "ACTIB", "strengthNumerator": "0.036", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BAICALIN", "unii": "347Q89U4M5", "classCode": "ACTIB", "strengthNumerator": "0.012", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LEUZEA CARTHAMOIDES ROOT", "unii": "P8CUH2KYHL", "classCode": "ACTIB", "strengthNumerator": "0.012", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "33.2616", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "DEANOL", "unii": "2N6K9DRA24", "classCode": "IACT", "strengthNumerator": "0.012", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "0.006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "ACTIB", "strengthNumerator": "0.006", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYCITRONELLAL", "unii": "8SQ0VA4YUR", "classCode": "ACTIB", "strengthNumerator": "0.0024", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "ACTIB", "strengthNumerator": "0.0018", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "3.036", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DECYL OLEATE", "unii": "ZGR06DO97T", "classCode": "ACTIB", "strengthNumerator": "3.9", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL STEARATE CITRATE", "unii": "WH8T92A065", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "60", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "ACTIB", "strengthNumerator": "2.1", "strengthDenominator": "60", "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: 2026-02-15T12:01:13.304357 · Updated: 2026-03-14T23:01:19.203951