SPL v2
SPL
SPL Set ID eaefe3b9-9064-18b1-e053-2a95a90a5765
Route
TOPICAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Betaine (5 g) Fragrance 13576 (0.125 g) Fd&c Blue No. 1 (0.00025 g) Benzoic Acid (1.75 g) Glycerin (2.25 g) Phenoxyethanol (2.75 g) Ethylhexylglycerin (0.1 g) Polysorbate 20 (232.139 mL) Water (0.75 g) Imidurea
Inactive Ingredients
Dehydroacetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-13 Until 2027-09-12

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.295968 · Updated: 2026-03-14T23:01:17.657881