SPL v1
SPL
SPL Set ID 35570155-c769-dc4c-e063-6394a90a019d
Route
TOPICAL
Published
Effective Date 2025-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Petroselinic Acid Ethylene-vinyl Acetate Copolymer (19% Vinylacetate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-17

Description

Nicotine


Medication Information

Warnings and Precautions

If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known.

Indications and Usage

Uses reduces withdrawal symptoms,includingnicotine craving,associated with quittingsmoking

Dosage and Administration

STEP1

Use one 21 mgpatch/day

Weeks 1-6

STEP 2

Use one 14 mg

patch/day

Weeks 7-8

STEP 3

Use one7mg

patch/day

Weeks9-10

Description

Nicotine

Section 50565-1

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets.If swallowed, get medical help or contact a Poison Control Center right away.Save pouch to use for patch di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.

Section 50567-7

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Section 50569-3

Ask a doctor or pharmacist before use ifyou are"usinga non-nicotine stop smoking drugtaking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted.

Section 51727-6

Inactive ingredientsethylene vinylacetate-copolymer, polyisobutylene and high densitypolyethylene between clearpolyester backings

Section 51945-4

Section 55105-1

Stop smoking aid

Section 55106-9

Nicotine


Structured Label Content

Indications and Usage (34067-9)

Uses reduces withdrawal symptoms,includingnicotine craving,associated with quittingsmoking

Dosage and Administration (34068-7)

STEP1

Use one 21 mgpatch/day

Weeks 1-6

STEP 2

Use one 14 mg

patch/day

Weeks 7-8

STEP 3

Use one7mg

patch/day

Weeks9-10

Warnings and Precautions (34071-1)

If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare provider.Smoking can seriously harm your child.Try to stop smoking without using any nicotine replacement medicine.This medicine is believed to safer than smoking.However, the risks to your child from this medicine are not full known.

Section 50565-1 (50565-1)

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets.If swallowed, get medical help or contact a Poison Control Center right away.Save pouch to use for patch di posal.Dispose of the used patches by folding sticky ends together and putting in pouch.

Section 50567-7 (50567-7)

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Section 50569-3 (50569-3)

Ask a doctor or pharmacist before use ifyou are"usinga non-nicotine stop smoking drugtaking a prescription medicine for depression or asthma.Your prescription dose may need to be adjusted.

Section 51727-6 (51727-6)

Inactive ingredientsethylene vinylacetate-copolymer, polyisobutylene and high densitypolyethylene between clearpolyester backings

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Nicotine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)