DailyMed - DailyMed Details

SPL v1

SPL

SPL Set ID 3c9425a7-4eb9-1a63-e063-6294a90a49a4

Route

TOPICAL

Published

Effective Date 2025-08-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Isopropyl Alcohol (72 mL)

Inactive Ingredients

Water Muscone, (+/-)- Benzyl Acetate Eugenol Hexamethylindanopyran 2-isobutyl-4-methyltetrahydropyran-4-ol Methyl Dihydrojasmonate (synthetic) Ethyl Linalool Ambroxide, (-)- Oxacyclohexadecenone Benzyl Alcohol Benzyl Benzoate Dipropylene Glycol Leuconostoc/radish Root Ferment Filtrate Ethylene Brassylate .alpha.-tocopherol 8-methoxycedrane Acetyl Cedrene Dioctyl Adipate Terpineol Linalyl Acetate 2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol Glycereth-26 Isocyclemone E Linalool, (+/-)- Dihydromyrcenol (mixed Isomers) Ethyl Vanillin Dihydro Pentamethylindanone Triethyl Citrate Geraniol .alpha.-hexylcinnamaldehyde Vanillin 2-tert-butylcyclohexyl Acetate Aloe Barbadensis Leaf Juice Diethyl Phthalate Cyclamen Aldehyde P-anisaldehyde Isopropyl Myristate Citral Caprylaldehyde Phenylethyl Alcohol .beta.-citronellol, (+/-)- Decanal Allyl Hexanoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-17

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

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Source: dailymed · Ingested: 2026-02-15T12:06:47.883007 · Updated: 2026-03-14T23:09:45.619768