ebf4b3ab-34e1-185a-e053-2a95a90ace3a

SPL v2
SPL
SPL Set ID ebf4b3ab-34e1-185a-e053-2a95a90ace3a
Route
topical
Published
Effective Date 2022-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
imidurea (3.75 g) aloe vera leaf (0.25 g) water (0.02 g)
Inactive Ingredients
sodium bicarbonate sodium hydroxide sodium benzoate potassium sorbate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2022-10-26 Until 2027-05-10


Medication Information

Warnings and Precautions

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1


Structured Label Content

Warnings and Precautions (34071-1)

Active Ingredient (55106-9)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)