SPL v2
SPL
SPL Set ID eb9244ea-6102-3cbe-e053-2a95a90ab8f6
Route
TOPICAL
Published
Effective Date 2022-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylparaben (0.0000001 g) Allantoin (0.0003 g) Panthenol (0.0125 g) Fd&c Yellow No. 5 (0.0025 g) Propylene Glycol (0.00005 g) Arctium Lappa Root (0.000049 g) Methylparaben (0.00001 g) Tioxolone (0.0069 g) Water (0.000035 g) Alcohol (0.00500065 g) Polyoxyl 40 Hydrogenated Castor Oil (0.01 g) Yeast, Unspecified (3.12515585 mL) Ascorbyl Palmitate (1.756 mL) Riboflavin (0.02 g) Ethylparaben (0.01725 g) Tocopherol (0.005 g) Citral (0.000003 g) Limonene, (+)- (0.00000015 g) Powdered Cellulose (0.000001 g) Isopropyl Alcohol (0.000097 g) Hydroxyethyl Cellulose, Unspecified (0.002095 g) Levomenol (0.0006 g) Farnesol (0.017 g) Fragrance 13576 (0.0015 g) Phenoxyethanol (0.0045 g) Butylparaben (0.0005 g) Niacinamide (0.00000025 g)
Inactive Ingredients
Thiamine Hydrochloride Pyridoxine Hydrochloride Vitamin A Palmitate Edetate Disodium Anhydrous .alpha.-tocopherol Acetate Sodium Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-21 Until 2027-09-20


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)