48697377-61c0-1b0a-e063-6294a90a3293

SPL v1

SPL

SPL Set ID 48697377-61c0-1b0a-e063-6294a90a3293

Route

topical

Published

Effective Date 2026-01-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

ectoin (0.0012 g) lidocaine (0.04 g) glycerin (0.06 g)

Inactive Ingredients

glyceryl stearate chlorphenesin peg-100 stearate triethanolamine methylparaben ci 16255 isopropyl myristate polysorbate 60 phenoxyethanol 1,2-hexanediol ci 19140 c13-14 isoparaffin laureth-7 water ethylhexyl palmitate trehalose carbomer panthenol butylene glycol sorbitan stearate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2026-01-19

Medication Information

Warnings and Precautions

Active Ingredient

Indications and Usage

Dosage and Administration

Section 44425-7

Section 50565-1

Section 50566-9

Section 50567-7

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 44425-7 (44425-7)

Section 50565-1 (50565-1)

Section 50566-9 (50566-9)

Section 50567-7 (50567-7)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:16.615458 · Updated: 2026-03-14T23:12:28.058882