SPL v2
SPL
SPL Set ID eb905bd0-c600-b8b2-e053-2995a90ad259
Route
TOPICAL
Published
Effective Date 2022-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (3.512 mL) Polyoxyl 40 Hydrogenated Castor Oil (0.04 g) Yeast, Unspecified (0.0345 g) Propylene Glycol (0.0138 g) Arctium Lappa Root (0.00007 g) Allantoin (0.025 g) Powdered Cellulose (0.0006 g) Propylparaben (0.0000002 g) Tocopherol (0.000002 g) Fragrance 13576 (0.005 g) Ethylparaben (0.02 g) Ascorbyl Palmitate (0.0001 g) Water (0.000098 g) Tioxolone (0.0000003 g) Levomenol (6.2503117 mL) Hydroxyethyl Cellulose, Unspecified (0.003 g) Isopropyl Alcohol (0.009 g) Farnesol (0.034 g) Methylparaben (0.0012 g) Panthenol (0.001 g) Phenoxyethanol (0.01 g) Butylparaben (0.0100013 g) Niacinamide (0.000006 g) Riboflavin (0.0000005 g) Citral (0.0002 g) Limonene, (+)- (0.000194 g) Fd&c Yellow No. 5 (0.00419 g)
Inactive Ingredients
Thiamine Hydrochloride .alpha.-tocopherol Acetate Pyridoxine Hydrochloride Vitamin A Palmitate Sodium Acetate Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-21 Until 2027-07-07


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


Raw Label Data

All Sections (JSON)