SPL v1
SPL
SPL Set ID 11f7a728-c7be-11a2-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (.0375 g) Menthol (5 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Propylparaben Aloe Vera Leaf Edetate Disodium Diazolidinyl Urea Methylparaben Iodopropynyl Butylcarbamate Glycerin Water Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-04-01


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 43685-7

Section 50565-1

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 43685-7 (43685-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)