SPL v4
SPL
SPL Set ID d0f883e5-b02c-cb8a-e053-2a95a90a90c1
Route
TOPICAL
Published
Effective Date 2021-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg) Menthol (1.75 mg)
Inactive Ingredients
.alpha.-bisabolol, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-30

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50567-7

Section 50569-3

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Section 60562-6

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 50567-7 (50567-7)

Section 50569-3 (50569-3)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Section 60562-6 (60562-6)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:49.486839 · Updated: 2026-03-14T22:59:57.476249