SPL v1
SPL
SPL Set ID 22c41042-6170-88b1-e063-6394a90a65e6
Route
TOPICAL
Published
Effective Date 2024-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alpha-arbutin (4 g) Tocopherol (2 g) Niacinamide Glutathione Nepidermin
Inactive Ingredients
Chamomile Glycerin Betaine Butylene Glycol Hyaluronate Sodium Tetrahexyldecyl Ascorbate Centella Asiatica Triterpenoids Magnesium Ascorbyl Phosphate Chrysanthellum Indicum Top Hydroxyethyl Urea Ceramide Ns 4-butylresorcinol Water Hyaluronic Acid Salicylic Acid Rosemary Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-23


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50566-9

Section 50567-7

Section 50569-3

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Section 59845-8

Section 60561-8


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 50566-9 (50566-9)

Section 50567-7 (50567-7)

Section 50569-3 (50569-3)

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)

Section 59845-8 (59845-8)

Section 60561-8 (60561-8)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)