SPL v2
SPL
SPL Set ID eaf0770c-795d-0232-e053-2a95a90ae0b5
Route
TOPICAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.96 mL) Glycerin (0.02 g) Lecithin, Soybean (0.12 g) Water (0.1 g) Malondialdehyde (0.04 g) Polyoxyl 35 Castor Oil (14.26 mL) Fragrance 13576 (2 g) Peg-8 Caprylic/capric Glycerides (0.18 g) Ferulic Acid (0.2 g)
Inactive Ingredients
Ascorbic Acid Deanol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-13 Until 2028-01-24


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)