3c9425a7-4eb9-1a63-e063-6294a90a49a4

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

Warnings and Precautions (34071-1)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

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)