SPL v2
SPL
SPL Set ID eaeeb6e0-5322-20c4-e053-2995a90a9fd9
Route
TOPICAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fd&c Blue No. 1 (0.0005 g) Lactic Acid (2.348125 g) Polyoxyl 40 Hydrogenated Castor Oil (1.25 g) Trolamine (0.5 g) .alpha.-hexylcinnamaldehyde (0.0150375 g) Linalool, (+/-)- (0.0041025 g) Benzoic Acid (0.625 g) Phenoxyethanol (2.5 g) Glycolic Acid (0.47 g) Water (1.220625 g) Allantoin (0.9375 g) Dehydroacetic Acid (228.15635 mL) Diethylene Glycol Monoethyl Ether (0.75 g) Fragrance 13576 (0.25 g) Limonene, (+)- (0.075 g) Propylene Glycol (0.022755 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-13 Until 2027-01-13

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: 2026-02-15T12:01:13.295306 · Updated: 2026-03-14T23:01:17.657881