Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb01a962-ab38-18ec-e053-2995a90acdeb Route TOPICAL Published Effective Date 2022-10-14 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Fragrance 13576 (0.15 g) Grape Seed Oil (0.00726 g) Glyceryl Monostearate (0.25 g) Linalool, (+/-)- (3.5 g) Phenoxyethanol (0.0114 g) Propylene Glycol (0.45 g) Titanium Dioxide (1.5 g) Palmitic Acid (1 g) Butylated Hydroxytoluene (5.5 g) Starch, Rice (4.752 mL) Alcohol (0.00639 g) C12-20 Acid Peg-8 Ester (4 g) Trolamine (0.0115 g) Isomethyl-.alpha.-ionone (0.05 g) Hydroxyacetophenone (0.012 g) Perlite (25.04945 g) Glycerin (0.75 g) Ethylhexylglycerin .beta.-citronellol, (r)- Water Stearic Acid Cetearyl Ethylhexanoate Inactive Ingredients Limonene, (+)- Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-14 Until 2027-10-13 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": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "0.00726", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GRAPE SEED OIL", "unii": "930MLC8XGG", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL 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"strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOMETHYL-.ALPHA.-IONONE", "unii": "9XP4LC555B", "classCode": "ACTIB", "strengthNumerator": "0.00639", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PERLITE", "unii": "0SG101ZGK9", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.0115", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".BETA.-CITRONELLOL, (R)-", "unii": "P01OUT964K", "classCode": "ACTIB", "strengthNumerator": "0.012", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "25.04945", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETEARYL ETHYLHEXANOATE", "unii": "9M64UO4C25", "classCode": "ACTIB", "strengthNumerator": "0.75", "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: 2026-02-15T12:01:13.297157 · Updated: 2026-03-14T23:01:17.657881
