SPL v1
SPL
SPL Set ID 3890a5df-0d91-1391-e063-6294a90a204c
Route
TOPICAL
Published
Effective Date 2025-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (72 mL)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Water Alpha-tocopherol Glycereth-26 Leuconostoc/radish Root Ferment Filtrate Diethyl Phthalate Ethyl Vanillin Benzyl Alcohol Allyl Hexanoate Linalool, (+/-)- Dipropylene Glycol Isocyclemone E Methyl Dihydrojasmonate (synthetic) Vanillin Ethylene Brassylate 2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol Muscone, (+/-)- Dihydro Pentamethylindanone Isobutyl Methyl Tetrahydropyranol Citral Terpineol Anisaldehyde Linalyl Acetate Citronellol Dioctyl Adipate 2-isobutyl-4-methyltetrahydropyran-4-ol Benzyl Benzoate Geraniol Ambroxide, (-)- Oxacyclohexadecenone Hexamethylindanopyran Ethyl Linalool Isopropyl Myristate Phenylethyl Alcohol Acetyl Cedrene .alpha.-hexylcinnamaldehyde Benzyl Acetate Eugenol Triethyl Citrate Dihydromyrcenol (mixed Isomers) Caprylaldehyde Decanal Cyclamen Aldehyde

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


Raw Label Data

All Sections (JSON)